Ventlab recall
Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF1140MB-D5, AF5142OB, AF5142MB, AF5142MB-D235, AF1142MBP, AF5142MBP, AF5140MB, AF5140MB-2, AF5140MB-D6, AF5140MB-F, AF1140MB-T, AF1140MB-PW, AF5140MB-PW, AF1140MB-I, AF5140MB-I, AF5140MBN, AF1140MBS, AF5140MBS, AF1140MB-X, AF5140MB-X, AF1140MB-P, AF5140MBP, AF1140MB-K, AF5140MBS-I,AF5140MBPF-G10, AF5140MBP-G10, AF1140MBP-T, AF5140MBP-I, AF1140MBP-K, AF1140MBC-N, AF1140MBP-2, AF1140MC, AF5140MC, AF1140MCP, AF5140MC-P, AF1100MB, AF5100MB, AF5100MC, AF1140MC-M5, AF1140MB-TM5, AF1140MBP-TM5, AF1100MC, AF1140OB, AF1140MBP-M5, AFW1140MB,AF1140MBS-P, AF1000MBN-20, AF5102MBP, AF1100MB-N, AF1100MC-P, AF1140MB, AF1140MB-E, AF1140MB-N, AF1140MB-R, AF1140MBS-K, AF1140MBSP-I, AF1142MB, AF1100MBS, AF1100MB-MMC, AF1100MB-PWG1, AF1100MBP; 2. AirFlow Child Resuscitator REF #s: AF4100MCP, AF4140MB, AF4140MB-I, AF4140MBP, AF4140MB-PI, AF4100MB, AF4100MBP, AF4100OB, AF4140MB-D23, AF4140OBP, AF4140MCP-D3, AF4140MC; 3. AirFlow Infant Resuscitator REF #s: AF3140OB, AF3144MB, AF3104MB-PW, AF3100MBP- M0D1, AF3100MBP- M012, AF3140MB-M000, AF3140MB-D2, AF3140MB-D1, AF3140MB-S1, AF3140MB-2B, AF3140MB-I, AF3140MB-K, AF3100MB-PW, AF3100MB-PTS1, AF3100MB-M0- D1, AF3100OC, AF3100MC-2, AF3100MC, AF3106MC-2, AF3140MCP-K, AF3140MC-2B, AF3100MCP-2, AF3140MC- M0D12, AF3144MCP- M1M00, AF3100OB, AF3140MB, AF3140MB-M0, AF3140MB-2, AF3140MB-M1, AF3140MB-PW, AF3140MB-P, AF3140MB-D12I, AF3140MBP-2, AF3140MC, AF3140MCP, AF3140MCPF, AF3100MB, AF3100MB-M0, AF3100MB-2, AF3100MB-M1, AF3100MB-X, AF3100MBP, AF3100MB-M01, AF3100MBP-M01, AF3100MBP-2, AF3100MBP-D12, AF3100MCP; 4. AirFlow Pediatric Resuscitator REF #s: AF2100OB, AF2100MB-3, AF2102OB, AF2100MB-D5, AF2140OB, AF2102MBP-2, AF2102MBPW-D4, AF2102MBP-M3, AF2140MB-2, AFW2142OB, AF2140MB-D4, AF2140MB-D43, AF2140MB-P2, AF2144MB, AFW2142MB-2, AF2142MB-D3, AF2242MBP, AF2142MBS-I, AF2142MBP- 224OT, AF2140MBPW- D23, AF2140MB-I, AF2140MB-K, AF2140MB-S, AF2140MBP-K, AF2100MB-PW, AF2100MB-MMC, AF2102MBP, AF2100MB- PWTS4, AF2140MCPF, AF2100MC, AF2102MC, AF2142MC-M01, AF2140MC, AF2142MC-D34, AF2140MCP-D4, AF2140MC-PT, AF2140MCP-K, AF2142MCP, AF2100MCP, AF2102MB, AF2102MCP, AF2102MC-PT, AF2142OB, AF2142OBNS, AF2142MB, AF2142MB-3, AF2142MB-2, AF2142MB-M5E, AF2142MB-PW, AF2142MBP, AF2142MB-K, AF2142MBP-2, AF2142MC-3, AF2142MCP-D4, AF2140MB, AF2140MB-PW, AF2140MBP, AF1142OB, AF2100MB; 5. AirFlow Small Adult Resuscitator REF #s: AF5140MC-D6, AF5140MB-M5, AF5100MB-D5, AF5142MBP-M5, AF5140MBPW-D5, AF5140MBPWTD5, AF5140MBP-D5, AF5140MBP-D6, AF5140MBPW- M5, AF5140MBP-M5, AFN5140MB, AF5140MB-OT, AF5140MB-T, AFD5140MB-T, AF5140MB-K, AF5140MBS-R, AF5140MBS-P, AF5140MB-PT, AF5140MB-ST, AF5140MCP-K, AF5100MB-PW, AF5102MB-N, AF5140MBS-M5. 6. Ventlab, LLC Resuscitation Kit REF # MC1000.
Why was Ventlab recalled?
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 10889483075814 (Item # AF1000MBN-20, Case UDI: 30889483075818); UDI-DI: 10889483076606 (Item # AF1100MB, Case UDI: 30889483076600); UDI-DI: 10889483076613 (Item # AF1100MB-MMC, Case UDI: 30889483076617); UDI-DI: 10889483075838 (Item # AF1100MB-N, Case UDI: 30889483075832); UDI-DI: 10889483088074 (Item # AF1100MBP, Case UDI: 30889483088078); UDI-DI: 10889483086209 (Item # AF1100MB-PWG1, Case UDI: 30889483086203); UDI-DI: 10889483086216 (Item # AF1100MBS, Case UDI: 30889483086210); UDI-DI: 10889483094365 (Item # AF1100MC, Case UDI: 30889483094369); UDI-DI: 10889483159217 (Item # AF1100MC-P, Case UDI: 30889483159211); UDI-DI: 10889483071809 (Item # AF1140MB, Case UDI: 30889483071803); UDI-DI: 10889483230626 (Item # AF1140MBC-N Case UDI: 30889483230620); UDI-DI: 10889483090718 (Item # AF1140MB-D5, Case UDI: 30889483090712); UDI-DI: 10889483106372 (Item # AF1140MB-E, Case UDI: 30889483106376); UDI-DI: 10889483095096 (Item # AF1140MB-I, Case UDI: 30889483095090); UDI-DI: 10889483083918 (Item # AF1140MB-K, Case UDI: 30889483083912); UDI-DI: 10889483162224 (Item # AF1140MB-M5, Case UDI: 30889483162228); UDI-DI: 10889483094372 (Item # AF1140MB-N, Case UDI: 30889483094376); UDI-DI: 10889483098370 (Item # AF1140MB-P, Case UDI: 30889483098374); UDI-DI: 10889483101469 (Item # AF1140MBP-2, Case UDI: 30889483101463); UDI-DI: 10889483106396 (Item # AF1140MBP-K, Case UDI: 30889483106390); UDI-DI: 10889483076637 (Item # AF1140MBP-M5, Case UDI: 30889483076631); UDI-DI: 10889483078143 (Item # AF1140MBP-T, Case UDI: 30889483078147); UDI-DI: 10889483162637 (Item # AF1140MBP-TM5, Case UDI: 30889483162631); UDI-DI: 10889483098387 (Item # AF1140MB-PW, Case UDI: 30889483098381); UDI-DI: 10889483074190 (Item # AF1140MB-R, Case UDI: 30889483074194); UDI-DI: 10889483095119 (Item # AF1140MBS, Case UDI: 30889483095113); UDI-DI: 10889483093320 (Item # AF1140MBS-K, Case UDI: 30889483093324); UDI-DI: 10889483076422 (Item # AF1140MBS-P, Case UDI: 30889483076426); UDI-DI: 10889483089088 (Item # AF1140MBSP-I, Case UDI: 30889483089082); UDI-DI: 10889483087213 (Item # AF1140MB-T, Case UDI: 30889483087217); UDI-DI: 10889483162439 (Item # AF1140MB-TM5, Case UDI: 30889483162433); UDI-DI: 10889483227589 (Item # AF1140MB-X, Case UDI: 30889483227583); UDI-DI: 10889483101476 (Item # AF1140MC, Case UDI: 30889483101470); UDI-DI: 10889483163146 (Item # AF1140MC-M5, Case UDI: 30889483163140); UDI-DI: 10889483097359 (Item # AF1140MCP, Case UDI: 30889483097353); UDI-DI: 10889483102121 (Item # AF1140OB, Case UDI: 30889483102125); UDI-DI: 10889483078150 (Item # AF1142MB, Case UDI: 30889483078154); UDI-DI: 10889483089255 (Item # AF1142MBP, Case UDI: 30889483089259); UDI-DI: 10889483089095 (Item # AF1142OB, Case UDI: 30889483089099); UDI-DI: 10889483096390 (Item # AF2100MB, Case UDI: 30889483096394); UDI-DI: 10889483076019 (Item # AF2100MB-3, Case UDI: 30889483076013); UDI-DI: 10889483171578 (Item # AF2100MB-D5, Case UDI: 30889483171572); UDI-DI: 10889483078181 (Item # AF2100MB-MMC, Case UDI: 30889483078185); UDI-DI: 10889483159231 (Item # AF2100MB-PW, Case UDI: 30889483159235); UDI-DI: 10889483102138 (Item # AF2100MB- PWTS4, Case UDI: 30889483102132); UDI-DI: 10889483090749 (Item # AF2100MC, Case UDI: 30889483090743); UDI-DI: 10889483101506 (Item # AF2100MCP, Case UDI: 30889483101500); UDI-DI: 10889483095706 (Item # AF2100OB, Case UDI: 30889483095700); UDI-DI: 10889483098394 (Item # AF2102MB, Case UDI: 30889483098398); UDI-DI: 10889483112977 (Item # AF2102MBP, Case UDI: 30889483112971); UDI-DI: 10889483076644 (Item # AF2102MBP-2, Case UDI: 30889483076648); UDI-DI: 10889483097304 (Item # AF2102MBP-M3, Case UDI: 30889483097308); UDI-DI: 10889483172285 (Item # AF2102MBPW-D4, Case UDI: 30889483172289); UDI-DI: 10889483158883 (Item # AF2102MC, Case UDI: 30889483158887); UDI-DI: 10889483078198 (Item # AF2102MCP, Case UDI: 30889483078192); UDI-DI: 10889483085769 (Item # AF2102MC-PT, Case UDI: 30889483085763); UDI-DI: 10889483077924 (Item # AF2102OB, Case UDI: 20889483077921); UDI-DI: 10889483078068 (Item # AF2140MB, Case UDI: 30889483078062); UDI-DI: 10889483081143 (Item # AF2140MB-2, Case UDI: 30889483081147); UDI-DI: 10889483076286 (Item # AF2140MB-D4, Case UDI: 30889483076280); UDI-DI: 10889483112984 (Item # AF2140MB-D43, Case UDI: 30889483112988); UDI-DI: 10889483077566 (Item # AF2140MB-I, Case UDI: 20889483077563); UDI-DI: 10889483081150 (Item # AF2140MB-K, Case UDI: 20889483081157); UDI-DI: 10889483088111 (Item # AF2140MBP, Case UDI: 30889483088115); UDI-DI: 10889483096413 (Item # AF2140MB-P2, Case UDI: 30889483096417); UDI-DI: 10889483083734 (Item # AF2140MBP-K, Case UDI: 30889483083738); UDI-DI: 10889483077573 (Item # AF2140MB-PW, Case UDI: 30889483077577); UDI-DI: 10889483159309 (Item # AF2140MBPW- D23, Case UDI: 30889483159303); UDI-DI: 10889483100424 (Item # AF2140MB-S, Case UDI: 30889483100428); UDI-DI: 10889483097311 (Item # AF2140MC, Case UDI: 20889483097318); UDI-DI: 10889483163344 (Item # AF2140MCP-D4, Case UDI: 30889483163348); UDI-DI: 10889483275788 (Item # AF2140MCPF, Case UDI: 30889483275782); UDI-DI: 10889483158821 (Item # AF2140MCP-K, Case UDI: 30889483158825); UDI-DI: 10889483159347 (Item # AF2140MC-PT, Case UDI: 30889483159341); UDI-DI: 10889483085776 (Item # AF2140OB, Case UDI: 30889483085770); UDI-DI: 10889483090237 (Item # AF2142MB , Case UDI: 30889483090231); UDI-DI: 10889483081167 (Item # AF2142MB-2, Case UDI: 30889483081161); UDI-DI: 10889483077931 (Item # AF2142MB-3, Case UDI: 30889483077935); UDI-DI: 10889483087756 (Item # AF2142MB-D3, Case UDI: 30889483087750); UDI-DI: 10889483088128 (Item # AF2142MB-K, Case UDI: 20889483088125); UDI-DI: 10889483102978 (Item # AF2142MBP, Case UDI: 30889483102972); UDI-DI: 10889483073315 (Item # AF2142MBP-2, Case UDI: 30889483073319); UDI-DI: 10889483097328 (Item # AF2142MBP- 224OT, Case UDI: 20889483097325); UDI-DI: 10889483102961 (Item # AF2142MB-PW, Case UDI: 20889483102968); UDI-DI: 10889483081174 (Item # AF2142MBS-I, Case UDI: 30889483081178); UDI-DI: 10889483081181 (Item # AF2142MC-3 , Case UDI: 30889483081185); UDI-DI: 10889483164136 (Item # AF2142MC-D34, Case UDI: 30889483164130); UDI-DI: 10889483168554 (Item # AF2142MC-M01, Case UDI: 30889483168558); UDI-DI: 10889483087800, (Item # AF2142MCP, Case UDI: 30889483087804); UDI-DI: 10889483167083 (Item # AF2142MCP-D4, Case UDI: 30889483167087); UDI-DI: 10889483089262 (Item # AF2142OB, Case UDI: 30889483089266); UDI-DI: 10889483226285 (Item # AF2142OBNS, Case UDI: 30889483226289); UDI-DI: 10889483078204 (Item # AF2144MB, Case UDI: 20889483078201); UDI-DI: 10889483555675 (Item # AF2142MB-M5E, Case UDI: 30889483555679); UDI-DI: 10889483077948 (Item # AF2242MBP, Case UDI: 20889483077945); UDI-DI: 10889483093542 (Item # AF3100MB, Case UDI: 30889483093546); UDI-DI: 10889483165171 (Item # AF3100MB-2, Case UDI: 30889483165175); UDI-DI: 10889483164556 (Item # AF3100MB-M0, Case UDI: 30889483164550); UDI-DI: 10889483085790 (Item # AF3100MB-M01, Case UDI: 20889483085797); UDI-DI: 10889483100431 (Item # AF3100MB-M0- D1, Case UDI: 30889483100435); UDI-DI: 10889483103432 (Item # AF3100MB-M1, Case UDI: 30889483103436); UDI-DI: 10889483089293 (Item # AF3100MBP, Case UDI: 30889483089297); UDI-DI: 10889483172254 (Item # AF3100MBP-2, Case UDI: 30889483172258); UDI-DI: 10889483159323 (Item # AF3100MBP-D12, Case UDI: 30889483159327); UDI-DI: 10889483083741 (Item # AF3100MBP-M01 Case UDI: 30889483083745 UDI-DI: 10889483158807 (Item # AF3100MBP- M012, Case UDI: 30889483158801); UDI-DI: 10889483165188 (Item # AF3100MBP- M0D1, Case UDI: 30889483165182); UDI-DI: 10889483087770 (Item # AF3100MB-PTS1, Case UDI: 30889483087774); UDI-DI: 10889483097335 (Item # AF3100MB-PW, Case UDI: 30889483097339); UDI-DI: 10889483228708 (Item # AF3100MB-X, Case UDI: 30889483228702); UDI-DI: 10889483081198 (Item # AF3100MC, Case UDI: 20889483081195); UDI-DI: 10889483077108 (Item # AF3100MC-2, Case UDI: 20889483077105); UDI-DI: 10889483089309 (Item # AF3100MCP, Case UDI: 30889483089303); UDI-DI: 10889483107447 (Item # AF3100MCP-2, Case UDI: 30889483107441); UDI-DI: 10889483075517 (Item # AF3100OB, Case UDI: 20889483075514); UDI-DI: 10889483097397 (Item # AF3100OC, Case UDI: 20889483097394); UDI-DI: 10889483172629 (Item # AF3104MB-PW, Case UDI: 30889483172623); UDI-DI: 10889483080023 (Item # AF3106MC-2, Case UDI: 30889483080027); UDI-DI: 10889483095713 (Item # AF3140MB, Case UDI: 30889483095717); UDI-DI: 10889483087220 (Item # AF3140MB-2, Case UDI: 30889483087224); UDI-DI: 10889483077115 (Item # AF3140MB-2B, Case UDI: 30889483077119); UDI-DI: 10889483078099 (Item # AF3140MB-D1, Case UDI: 30889483078093); UDI-DI: 10889483102985 (Item # AF3140MB-D12I, Case UDI: 30889483102989); UDI-DI: 10889483097342 (Item # AF3140MB-D2, Case UDI: 30889483097346); UDI-DI: 10889483087824 (Item # AF3140MB-I, Case UDI: 30889483087828); UDI-DI: 10889483103449 (Item # AF3140MB-K, Case UDI: 30889483103443); UDI-DI: 10889483077214 (Item # AF3140MB-M0, Case UDI: 30889483077218); UDI-DI: 10889483082683 (Item # AF3140MB-M000, Case UDI: 30889483082687); UDI-DI: 10889483102992 (Item # AF3140MB-M1, Case UDI: 30889483102996); UDI-DI: 10889483113011 (Item # AF3140MB-P, Case UDI: 30889483113015); UDI-DI: 10889483096444 (Item # AF3140MBP-2, Case UDI: 30889483096448); UDI-DI: 10889483159910 (Item # AF3140MB-PW, Case UDI: 30889483159914); UDI-DI: 10889483090299 (Item # AF3140MB-S1, Case UDI: 30889483090293); UDI-DI: 10889483079256 (Item # AF3140MC, Case UDI: 30889483079250); UDI-DI: 10889483077597 (Item # AF3140MC-2B, Case UDI: 30889483077591); UDI-DI: 10889483232088 (Item # AF3140MC- M0D12 UDI-DI: 10889483166963 (Item # AF3140MCP, Case UDI: 30889483166967); UDI-DI: 10889483275771 (Item # AF3140MCPF, Case UDI: 30889483275775); UDI-DI: 1088948315881 (Item # AF3140MCP-K, Case UDI: 30889483158818); UDI-DI: 10889483097410 (Item # AF3140OB, Case UDI: 30889483097414); UDI-DI: 10889483078105 (Item # AF3144MB, Case UDI: 30889483078109); UDI-DI: 10889483272626 (Item # AF3144MCP- M1M00, Case UDI: 30889483272620); UDI-DI: 10889483090305 (Item # AF4100MB, Case UDI: 30889483090309); UDI-DI: 10889483160121 (Item # AF4100MBP, Case UDI: 30889483160125); UDI-DI: 10889483182246 (Item # AF4100MCP, Case UDI: 30889483182240); UDI-DI: 10889483098417 (Item # AF4100OB, Case UDI: 30889483098411); UDI-DI: 10889483077627 (Item # AF4140MB, Case UDI: 30889483077621); UDI-DI: 10889483090510 (Item # AF4140MB-D23, Case UDI: 30889483090514); UDI-DI: 10889483093559 (Item # AF4140MB-I, Case UDI: 30889483093553); UDI-DI: 10889483099209 (Item # AF4140MBP, Case UDI: 30889483099203); UDI-DI: 10889483079287 (Item # AF4140MB-PI, Case UDI: 30889483079281); UDI-DI: 10889483087237 (Item # AF4140MC, Case UDI: 30889483087231); UDI-DI: 10889483163337 (Item # AF4140MCP-D3, Case UDI: 30889483163331); UDI-DI: 10889483090527 (Item # AF4140OBP, Case UDI: 30889483090521); UDI-DI: 10889483089323 (Item # AF5100MB, Case UDI: 30889483089327); UDI-DI: 10889483089330 (Item # AF5100MB-D5, Case UDI: 30889483089334); UDI-DI: 10889483159224 (Item # AF5100MB-PW, Case UDI: 30889483159228); UDI-DI: 10889483099346 (Item # AF5100MC, Case UDI: 30889483099340); UDI-DI: 10889483171929 (Item # AF5102MB-N, Case UDI: 30889483171923); UDI-DI: 10889483165164 (Item # AF5102MBP, Case UDI: 30889483165168); UDI-DI: 10889483103012 (Item # AF5140MB, Case UDI: 30889483103016); UDI-DI: 10889483079881 (Item # AF5140MB-2, Case UDI: 30889483079885); UDI-DI: 10889483089606 (Item # AF5140MB-D6, Case UDI: 30889483089600); UDI-DI: 10889483083758 (Item # AF5140MB-F, Case UDI: 30889483083752); UDI-DI: 10889483087251 (Item # AF5140MB-I, Case UDI: 30889483087255); UDI-DI: 10889483082720 (Item # AF5140MB-K, Case UDI: 30889483082724); UDI-DI: 10889483162408 (Item # AF5140MB-M5, Case UDI: 30889483162402); UDI-DI: 10889483090275 (Item # AF5140MBN, Case UDI: 30889483090279); UDI-DI: 10889483103029 (Item # AF5140MB-OT, Case UDI: 30889483103023); UDI-DI 10889483074725 (Item # AF5140MBP, Case UDI: 30889483074729 UDI-DI: 10889483098431 (Item # AF5140MBP-D5, Case UDI: 30889483098435); UDI-DI: 10889483104682 (Item # AF5140MBP-D6, Case UDI: 30889483104686); UDI-DI: 10889483275757 (Item # AF5140MBPF-G10, Case UDI: 30889483275751); UDI-DI: 10889483171967 (Item # AF5140MBP-G10, Case UDI: 30889483171961); UDI-DI: 10889483072233 (Item # AF5140MBP-I , Case UDI: 30889483072237); UDI-DI: 10889483163085 (Item # AF5140MBP-M5, Case UDI: 30889483163089); UDI-DI: 10889483089347 (Item # AF5140MB-PT, Case UDI: 30889483089341); UDI-DI: 10889483080061 (Item # AF5140MB-PW, Case UDI: 30889483080065); UDI-DI: 10889483099216 (Item # AF5140MBPW-D5, Case UDI: 30889483099210); UDI-DI: 10889483162514 (Item # AF5140MBPW- M5, Case UDI: 30889483162518); UDI-DI: 10889483079133 (Item # AF5140MBPWTD5, Case UDI: 30889483079137); UDI-DI: 10889483083772 (Item # AF5140MBS, Case UDI: 30889483083776); UDI-DI: 10889483077139 (Item # AF5140MBS-I, Case UDI: 30889483077133); UDI-DI: 10889483162231 (Item # AF5140MBS-M5, Case UDI: 30889483162235); UDI-DI: 10889483087268 (Item # AF5140MBS-P, Case UDI: 30889483087262); UDI-DI: 10889483083789 (Item # AF5140MBS-R, Case UDI: 30889483083783); UDI-DI: 10889483092682 (Item # AF5140MB-ST, Case UDI: 30889483092686); UDI-DI: 10889483083765 (Item # AF5140MB-T, Case UDI: 30889483083769); UDI-DI: 10889483227619 (Item # AF5140MB-X, Case UDI: 30889483227613); UDI-DI: 10889483090282 (Item # AF5140MC, Case UDI: 30889483090286); UDI-DI: 10889483228241 (Item # AF5140MC-D6, Case UDI: 30889483228245); UDI-DI: 10889483104200 (Item # AF5140MC-P, Case UDI: 30889483104204); UDI-DI: 10889483158838 (Item # AF5140MCP-K, Case UDI: 30889483158832); UDI-DI: 10889483089613 (Item # AF5142MB, Case UDI: 30889483089617); UDI-DI: 10889483227305 (Item # AF5142MB-D235, Case UDI: 30889483227309); UDI-DI: 10889483091838 (Item # AF5142MBP, Case UDI: 30889483091832); UDI-DI: 10889483163177 (Item # AF5142MBP-M5, Case UDI: 30889483163171); UDI-DI: 10889483080078 (Item # AF5142OB, Case UDI: 30889483080072); UDI-DI: 10889483085127 (Item # AFD5140MB-T, Case UDI: 30889483085121); UDI-DI: 10889483162781 (Item # AFN5140MB, Case UDI: 30889483162785); UDI-DI: 10889483099247 (Item # AFW1140MB, Case UDI: 30889483099241 UDI-DI: 10889483092705 (Item# AFW2142MB-2, Case UDI: 30889483092709); UDI-DI: 10889483078709 (Item # AFW2142OB, Case UDI: 30889483078703). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.
- Product
- Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF1140MB-D5, AF5142OB, AF5142MB, AF5142MB-D235, AF1142MBP, AF5142MBP, AF5140MB, AF5140MB-2, AF5140MB-D6, AF5140MB-F, AF1140MB-T, AF1140MB-PW, AF5140MB-PW, AF1140MB-I, AF5140MB-I, AF5140MBN, AF1140MBS, AF5140MBS, AF1140MB-X, AF5140MB-X, AF1140MB-P, AF5140MBP, AF1140MB-K, AF5140MBS-I,AF5140MBPF-G10, AF5140MBP-G10, AF1140MBP-T, AF5140MBP-I, AF1140MBP-K, AF1140MBC-N, AF1140MBP-2, AF1140MC, AF5140MC, AF1140MCP, AF5140MC-P, AF1100MB, AF5100MB, AF5100MC, AF1140MC-M5, AF1140MB-TM5, AF1140MBP-TM5, AF1100MC, AF1140OB, AF1140MBP-M5, AFW1140MB,AF1140MBS-P, AF1000MBN-20, AF5102MBP, AF1100MB-N, AF1100MC-P, AF1140MB, AF1140MB-E, AF1140MB-N, AF1140MB-R, AF1140MBS-K, AF1140MBSP-I, AF1142MB, AF1100MBS, AF1100MB-MMC, AF1100MB-PWG1, AF1100MBP; 2. AirFlow Child Resuscitator REF #s: AF4100MCP, AF4140MB, AF4140MB-I, AF4140MBP, AF4140MB-PI, AF4100MB, AF4100MBP, AF4100OB, AF4140MB-D23, AF4140OBP, AF4140MCP-D3, AF4140MC; 3. AirFlow Infant Resuscitator REF #s: AF3140OB, AF3144MB, AF3104MB-PW, AF3100MBP- M0D1, AF3100MBP- M012, AF3140MB-M000, AF3140MB-D2, AF3140MB-D1, AF3140MB-S1, AF3140MB-2B, AF3140MB-I, AF3140MB-K, AF3100MB-PW, AF3100MB-PTS1, AF3100MB-M0- D1, AF3100OC, AF3100MC-2, AF3100MC, AF3106MC-2, AF3140MCP-K, AF3140MC-2B, AF3100MCP-2, AF3140MC- M0D12, AF3144MCP- M1M00, AF3100OB, AF3140MB, AF3140MB-M0, AF3140MB-2, AF3140MB-M1, AF3140MB-PW, AF3140MB-P, AF3140MB-D12I, AF3140MBP-2, AF3140MC, AF3140MCP, AF3140MCPF, AF3100MB, AF3100MB-M0, AF3100MB-2, AF3100MB-M1, AF3100MB-X, AF3100MBP, AF3100MB-M01, AF3100MBP-M01, AF3100MBP-2, AF3100MBP-D12, AF3100MCP; 4. AirFlow Pediatric Resuscitator REF #s: AF2100OB, AF2100MB-3, AF2102OB, AF2100MB-D5, AF2140OB, AF2102MBP-2, AF2102MBPW-D4, AF2102MBP-M3, AF2140MB-2, AFW2142OB, AF2140MB-D4, AF2140MB-D43, AF2140MB-P2, AF2144MB, AFW2142MB-2, AF2142MB-D3, AF2242MBP, AF2142MBS-I, AF2142MBP- 224OT, AF2140MBPW- D23, AF2140MB-I, AF2140MB-K, AF2140MB-S, AF2140MBP-K, AF2100MB-PW, AF2100MB-MMC, AF2102MBP, AF2100MB- PWTS4, AF2140MCPF, AF2100MC, AF2102MC, AF2142MC-M01, AF2140MC, AF2142MC-D34, AF2140MCP-D4, AF2140MC-PT, AF2140MCP-K, AF2142MCP, AF2100MCP, AF2102MB, AF2102MCP, AF2102MC-PT, AF2142OB, AF2142OBNS, AF2142MB, AF2142MB-3, AF2142MB-2, AF2142MB-M5E, AF2142MB-PW, AF2142MBP, AF2142MB-K, AF2142MBP-2, AF2142MC-3, AF2142MCP-D4, AF2140MB, AF2140MB-PW, AF2140MBP, AF1142OB, AF2100MB; 5. AirFlow Small Adult Resuscitator REF #s: AF5140MC-D6, AF5140MB-M5, AF5100MB-D5, AF5142MBP-M5, AF5140MBPW-D5, AF5140MBPWTD5, AF5140MBP-D5, AF5140MBP-D6, AF5140MBPW- M5, AF5140MBP-M5, AFN5140MB, AF5140MB-OT, AF5140MB-T, AFD5140MB-T, AF5140MB-K, AF5140MBS-R, AF5140MBS-P, AF5140MB-PT, AF5140MB-ST, AF5140MCP-K, AF5100MB-PW, AF5102MB-N, AF5140MBS-M5. 6. Ventlab, LLC Resuscitation Kit REF # MC1000.
- Recalling firm
- SunMed Holdings, LLC
- Quantity
- N/A
- Distribution
- US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.
- Recall date
- November 29, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)