Medline procedure kits labeled as: 1) ABLATION PACK recall
Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Number DYNJ67756A; 3) CHRISTUS WH LAP…
Why was Medline procedure kits labeled as: 1) ABLATION PACK recalled?
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
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?
1) Pack Number DYNJ40629B: UDI/DI 10888277778696 (each) 40888277778697 (case), Lot number 21EME542A; 2) Pack Number DYNJ67756A: UDI/DI 10193489847079 (each) 40193489847070 (case), Lot number 21LBH976A; 3) Pack Number DYNJ60934B: UDI/DI 10195327080785 (each) 40195327080786 (case), Lot number 22GBX458A; 4) Pack Number DYNJ61095D: UDI/DI 10195327452674 (each) 40195327452675 (case), Lot number 23LMF912A; 5) Pack Number DYNJ80438: UDI/DI 10195327038557 (each) 40195327038558 (case), Lot number 22GBI566A; 6) Pack Number DYNJ0426069N: UDI/DI 10195327371319 (each) 40195327371310 (case), Lot number 23HMC076A; 7) Pack Number DYNJ50915B: UDI/DI 10193489213478 (each) 40193489213479 (case), Lot number 23EMC403A; 8) Pack Number DYNJ63363G: UDI/DI 10195327273330 (each) 40195327273331 (case), Lot number 23HMC803A; 9) Pack Number DYNJ0415393J: UDI/DI 10193489803273 (each) 40193489803274 (case), Lot number 21JMH176A; 10) Pack Number DYNJ66729: UDI/DI 10193489374933 (each) 40193489374934 (case), Lot number 22GBH503A; 11) Pack Number DYNJ60998: UDI/DI 10193489546149 (each) 40193489546140 (case), Lot number 21GMD619A; 12) Pack Number DYNJ51663B: UDI/DI 10889942965250 (each) 40889942965251 (case), Lot number 22CMG200A; 13) Pack Number DYNJ59943C: UDI/DI 10195327042547 (each) 40195327042548 (case), Lot number 21LBI099A; 14) Pack Number DYNJ904625D: UDI/DI 10193489419863 (each) 40193489419864 (case), Lot number 22IBD797Z; 15) Pack Number DYNJ902780D: UDI/DI 10193489221329 (each) 40193489221320 (case), Lot number 23GBO958Z; 16) Pack Number DYNJ83414: UDI/DI 10195327264949 (each) 40195327264940 (case), Lot number 23FMD507A; 17) Pack Number DYNJ51502A: UDI/DI 10193489686326 (each) 40193489686327 (case), Lot number 21BBD357A; 18) Pack Number DYNJ16657G: UDI/DI 10193489362619 (each) 40193489362610 (case), Lot number 21GMD931A; 19) Pack Number DYNJ37370B: UDI/DI 10889942223633 (each) 40889942223634 (case), Lot number 21IMF238A; 20) Pack Number DYNJ26209N: UDI/DI 10193489483161 (each) 40193489483162 (case), Lot number 22CMF620A; 21) Pack Number DYNJ04581P: UDI/DI 10193489555479 (each) 40193489555470 (case), Lot number 23DMB984A; 22) Pack Number DYNJ67745A: UDI/DI 10195327409401 (each) 40195327409402 (case), Lot number 24ABA563Z; 23) Pack Number DYNJ09820J: UDI/DI 10888277840928 (each) 40888277840929 (case), Lot number 21BBG608A; 24) Pack Number DYNJ48884C: UDI/DI 10193489476651 (each) 40193489476652 (case), Lot number 21LMF921A; 25) Pack Number DYNJ57709B: UDI/DI 10193489424065 (each) 40193489424066 (case), Lot number 23JBR204A; 26) Pack Number DYNJ80172B: UDI/DI 10195327359188 (each) 40195327359189 (case), Lot number 23FBM928A; 27) Pack Number DYNJ46550F: UDI/DI 10193489338812 (each) 40193489338813 (case), Lot number 20LKB332A; 28) Pack Number DYNJ63472: UDI/DI 10193489745597 (each) 40193489745598 (case), Lot number 23EBD908A; 29) Pack Number DYNJ902455I: UDI/DI 10193489309584 (each) 40193489309585 (case), Lot number 20HBJ365Z; 30) Pack Number DYNJ61652: UDI/DI 10193489586855 (each) 40193489586856 (case), Lot number 20JKA923A; 31) Pack Number DYNJHS0235C: UDI/DI 10889942635245 (each) 40889942635246 (case), Lot number 21JMA297A; 32) Pack Number DYNJ21605J: UDI/DI 10195327108700 (each) 40195327108701 (case), Lot number 22BMG822Z; 33) Pack Number DYNJ52642F: UDI/DI 10195327441302 (each) 40195327441303 (case), Lot number 23HMB247A; 34) Pack Number DYNJ59313B: UDI/DI 10195327248338 (each) 40195327248339 (case), Lot number 23LME174A; 35) Pack Number DYNJ902039F: UDI/DI 10195327390631 (each) 40195327390632 (case), Lot number 23GBO615Z; 36) Pack Number DYNJ83049: UDI/DI 10195327234300 (each) 40195327234301 (case), Lot number 23AMI041A; 37) Pack Number DYNJ66821A: UDI/DI 10193489974928 (each) 40193489974929 (case), Lot number 23IBJ792A; 38) Pack Number DYNJ16629D: UDI/DI 10889942870585 (each) 40889942870586 (case), Lot number 20HKB315A; 39) Pack Number DYNJ67695A: UDI/DI 10195327512200 (each) 40195327512201 (case), Lot number 23LMG985A; 40) Pack Number DYNJS3032: UDI/DI 10884389408407 (each) 40884389408408 (case), Lot number 23BBO868Z; 41) Pack Number DYNJ44675K: UDI/DI 10195327127480 (each) 40195327127481 (case), Lot number 23BDA249A; 42) Pack Number DYNJ46190G: UDI/DI 10195327213855 (each) 40195327213856 (case), Lot number 23EMD906A; 43) Pack Number DYNJ68885A: UDI/DI 10195327187453 (each) 40195327187454 (case), Lot number 23FBO338A; 44) Pack Number DYNJ45578B: UDI/DI 10195327059187 (each) 40195327059188 (case), Lot number 23GBD205A; 45) Pack Number DYNJ43784A: UDI/DI 10889942903047 (each) 40889942903048 (case), Lot number 23HME180A; 46) Pack Number DYNJ04690Y: UDI/DI 10195327381752 (each) 40195327381753 (case), Lot number 23DME413A; 47) Pack Number DYNJQ0629F: UDI/DI 10889942565559 (each) 40889942565550 (case), Lot number 21FBP134A; 48) Pack Number DYNJ69256: UDI/DI 10193489918151 (each) 40193489918152 (case), Lot number 21JMI098A; 49) Pack Number DYNJ49310F: UDI/DI 10195327546373 (each) 40195327546374 (case), Lot number 23LMF829A; 50) Pack Number DYNJ19521P: UDI/DI 10193489941197 (each) 40193489941198 (case), Lot number 21IMD905A; 51) Pack Number DYNJ49947G: UDI/DI 10193489474152 (each) 40193489474153 (case), Lot number 21GMD742A; 52) Pack Number DYNJ51573C: UDI/DI 10195327561222 (each) 40195327561223 (case), Lot number 23LMG544A; 53) Pack Number DYNJ51575B: UDI/DI 10195327132248 (each) 40195327132249 (case), Lot number 22JMB950A; 54) Pack Number DYNJ52087J: UDI/DI 10195327467104 (each) 40195327467105 (case), Lot number 23LMD323A; 55) Pack Number DYNJ52087J: UDI/DI 10195327467104 (each) 40195327467105 (case), Lot number 23LMD611A; 56) Pack Number DYNJ55538B: UDI/DI 10193489574630 (each) 40193489574631 (case), Lot number 21BBG139A; 57) Pack Number DYNJ44022B: UDI/DI 10193489429329 (each) 40193489429320 (case), Lot number 22DBR220Z; 58) Pack Number DYNJ47704G: UDI/DI 10195327380724 (each) 40195327380725 (case), Lot number 23FMF488A; 59) Pack Number DYNJ82688: UDI/DI 10195327202903 (each) 40195327202904 (case), Lot number 23LMG154A; 60) Pack Number DYNJ82436A: UDI/DI 10195327362607 (each) 40195327362608 (case), Lot number 23EMD052A; 61) Pack Number DYNJ83622: UDI/DI 10195327285753 (each) 40195327285754 (case), Lot number 23FBN812A; 62) Pack Number DYNJ0785763L: UDI/DI 10193489351095 (each) 40193489351096 (case), Lot number 21LMF965A; 63) Pack Number DYNJ49994I: UDI/DI 10195327065775 (each) 40195327065776 (case), Lot number 21LMF123A; 64) Pack Number DYNJ66233A: UDI/DI 10195327176600 (each) 40195327176601 (case), Lot number 23LME717A; 65) Pack Number DYNJ55378C: UDI/DI 10193489443776 (each) 40193489443777 (case), Lot number 22GBJ071A; 66) Pack Number DYNJ69574A: UDI/DI 10195327242473 (each) 40195327242474 (case), Lot number 22JBI116Z; 67) DYNJ0365463J: UDI/DI 10193489783872 (each) 40193489783873 (case), Lot Number 22CMA803A; 68) DYNJ0365463J: UDI/DI 10193489783872 (each) 40193489783873 (case), Lot Number 22KMA579A; 69) DYNJ0365463J: UDI/DI 10193489783872 (each) 40193489783873 (case), Lot Number 22KMA581A
- Product
- Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Number DYNJ67756A; 3) CHRISTUS WH LAP…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 11,774 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall date
- April 2, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)