TruWave with Vamp System Pressure monitoring set recall
TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm)…
Why was TruWave with Vamp System Pressure monitoring set recalled?
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
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?
PXAVMP:UDI: 00690103011494/Lot # 64817849; PXAVMP3: UDI:07460691950085/Lot # 64918575; PXVK0364:UDI:07460691954526/Lot # 64858007; PXVK0853: UDI: 07460691957671/Lot # 65060361; PXVK0996:UDI: 07460691955431/Lot # 64858275; PXVMP2X21:UDI: 07460691950115/Lot # 64992080; PXVMP2X22: UDI: 00690103016765/Lot # 64891427; PXVMP3X32:UDI: 0690103016802/Lot # 65008748; PXVP0041: UDI: 00690103197983/Lot # 64835537; PXVP0550:UDI: 07460691949911/Lot # 64818013, 64858077, 64891424, 64918588, 64985484; PXVP1071: UDI: 07460691955462/Lot # 64807998, 64807999; PXVP1087: UDI: 07460691957886/Lot # 65035078, 65079515; PXVP2260: UDI: 07460691950108/Lot # 64858071, 64858103, 64891419, 64906892; PXVP2272:UDI: 07460691950184/Lot # 64752261, 64906891, 65138017; PXVP2284: UDI: 07460691950177/Lot # 64818005, 64818008, 64818011, 64891421, 64933492, 64933493, 64964755, 64964759, 64964760, 64964761, 64998878, 65060446; PXVP2284AT3: UDI: 07460691950436/Lot # 64722680, 64858285, 64951434, 64980108, 64992088; PXVP23X3:UDI: 07460691950092/Lot # 64998879, 65060444; PXVP23X3AT3: UDI: 07460691950443/Lot # 64695848, 64779289, 64858072, 64858290, 64992092,65060447; PXVP2X2AT3: UDI:07460691950467/Lot # 64858075; PXVPL0111: UDI: 00690103200386/Lot # 64933462; PXVMP160: UDI:/Lot # 64779279, 64918578, 64933556, 64933559; PXVMP172: UDI:/Lot # 64835579; PXVMP184:UDI:/Lot # 64949045, 64983460, 65042811; PXVMP260:UDI:/Lot # 64629075, 64964750, 64980101; PXVFL10017:UDI:00690103210798/Lot # 64923241; PXVP0034:UDI:00690103197945/Lot # 64835538, 65019842; T001691A:UDI: 07460691947627/Lot # 64793360 64807977 64817834 64835567 64835568 65008739 65019862 65035054 65048943; T001744M:UDI: 07460691959507/Lot # 64526411, 64891383; T100671M:UDI: 07460691959491/Lot # 64912244; T001760A: UDI:07460691947566/ Lot # 65008764, 65019890, 65067580; T001765A: UDI:07460691947290/ Lot # 64891376, 64906871, 64980035, 64983290, 65035029; T005021M:UDI:07460691959538/ Lot # 64858230, 64923245; T005089M:UDI:07460691959545/Lot #64933442, 65060364 T005091M:UDI:07460691959552/Lot # 64807926 T434501B:UDI: 07460691956636/ Lot # 64817812 T440B26B:UDI:07460691949553/ Lot # 64817809, 64817936; T450545A:UDI: 07460691931572/ Lot # 65035081; T460241A: UDI:07460691949188/ Lot # 64933451; T530219D:UDI:07460691948259/ Lot # 65067546
- Product
- TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm)…
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 168,014 units
- Distribution
- US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA WA WI WV WY OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Netherlands New Zealand Northern Ireland Norway Panama Poland Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Arab Emirates (UAE) United Kingdom Vietnam
- Recall date
- December 6, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)