Recall Z-2623-2024
MEDLINE INDUSTRIES, LP - Northfield · initiated April 8, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2) FTMC LOCAL PACK-LF, pack number DYNJ54607A, 3) LOCAL PACK, pack number DYNJ61839B
Codes / lots: DYNJ34129C , Lot Number 21GBT130 , DYNJ34129C , Lot Number 21LBL623 , DYNJ34129C , Lot Number 22ABM033 , DYNJ34129C , Lot Number 22ABX499 , DYNJ34129C , Lot Number 19BBD954 , DYNJ34129C , Lot Number 19DBZ455 , DYNJ34129C , Lot Number 19EBU077 , DYNJ34129C , Lot Number 19GBU537 , DYNJ34129C , Lot Number 22IBG550 , DYNJ34129C , Lot Number 19JBN034 , DYNJ34129C , Lot Number 20BBF056 , DYNJ34129C , Lot Number 23FBG792 , DYNJ34129C , Lot Number 23GBE376 , DYNJ34129C , Lot Number 20FBS002 , DYNJ34129C , Lot Number 23JBR570 , DYNJ34129C , Lot Number 23JBY629 , DYNJ34129C , Lot Number 23KBU960 , DYNJ34129C , Lot Number 23KBW607 , DYNJ34129C , Lot Number 20KBW597 , DYNJ34129C , Lot Number 20LBM567 , DYNJ34129C , Lot Number 21EBA688 , DYNJ54607A , Lot Number 21HBS933 , DYNJ54607A , Lot Number 21JBH960 , DYNJ54607A , Lot Number 21JBZ002 , DYNJ54607A , Lot Number 21LBJ925 , DYNJ54607A , Lot Number 19BBP092 , DYNJ54607A , Lot Number 19CBB568 , DYNJ54607A , Lot Number 22GBH746 , DYNJ54607A , Lot Number 22GBZ352 , DYNJ54607A , Lot Number 19GBT320 , DYNJ54607A , Lot Number 22IBG226 , DYNJ54607A , Lot Number 19VBA464 , DYNJ54607A , Lot Number 19LBN255 , DYNJ54607A , Lot Number 23EBA098…
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.
Details
- Recall number
- Z-2623-2024
- Initiated
- April 8, 2024
- Posted by FDA
- August 27, 2024
- Product code
- OFQ – Anesthesia Kit
- Quantity
- 1,679,067 units in total
- Distribution
- Worldwide distribution.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2624-2024 Class II | see RES for descriptionMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2625-2024 Class II | See RES DescriptionMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2626-2024 Class II | See RES descriptionMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2627-2024 Class II | Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2628-2024 Class II | See RES descriptionMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2629-2024 Class II | Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2630-2024 Class II | Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2631-2024 Class II | Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC DOUBLE…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2632-2024 Class II | Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2633-2024 Class II | Medline procedure packs containing Shenli syringes, labeled as follows: NEURO ANGIO…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2634-2024 Class II | Medline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B ; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| Z-2635-2024 Class II | Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |