Recall Z-2626-2024
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
See RES description
Codes / lots: CDS981579O , Lot Number 21JBM647 ; CDS981579O , Lot Number 21JBQ860 ; CDS981579O , Lot Number 22CBX741 ; CDS981579O , Lot Number 19EBL586 ; CDS981579O , Lot Number 19GBJ538 ; CDS981579O , Lot Number 19IBH976 ; CDS981579O , Lot Number 19JBZ536 ; CDS981579O , Lot Number 19KBB918 ; CDS981579O , Lot Number 20ABP061 ; CDS981579O , Lot Number 20BBA647 ; CDS981579O , Lot Number 20DBM006 ; CDS981579O , Lot Number 20FBS525 ; CDS981579O , Lot Number 21ABO831 ; CDS981579O , Lot Number 21BBI363 ; CDS981579O , Lot Number 21CBI409 ; CDS981579O , Lot Number 21DBG604 ; CDS981579O , Lot Number 21FBC673 ; DYNDA2391, Lot Number 21JBR496 ; DYNDA2508, Lot Number 19FBY839 ; DYNJ0117039, Lot Number 19ALA192 ; DYNJ0117039, Lot Number 19FLA299 ; DYNJ0117039, Lot Number 19LLA121 ; DYNJ0117039, Lot Number 20ALA869 ; DYNJ0117039, Lot Number 20CLA195 ; DYNJ0117039, Lot Number 20GLA412 ; DYNJ0117039, Lot Number 20ILA113 ; DYNJ0117039, Lot Number 20JLA806 ; DYNJ0117039, Lot Number 20KLA286 ; DYNJ0117039, Lot Number 21ALA145 ; DYNJ0134147D , Lot Number 21JBP263 ; DYNJ0134147D , Lot Number 22ABI678 ; DYNJ0134147D , Lot Number 22EMB713 ; DYNJ0134147D , Lot Number 23CMA573 ; DYNJ0134147D , Lot Number 23GMB375…
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-2626-2024
- Initiated
- April 8, 2024
- Posted by FDA
- August 27, 2024
- Product code
- OGJ – Nerve Block Tray
- 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-2623-2024 Class II | Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 04/08/2024Open, Classified |
| 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-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 |