Recall Z-2625-2024
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: DYNJ0708470K , Lot Number 19ALA269 ; DYNJ0708470K , Lot Number 19ELA237 ; DYNJ0708470K , Lot Number 19FLA396 ; DYNJ0708470K , Lot Number 19GLA166 ; DYNJ0708470K , Lot Number 19HLA649 ; DYNJ0708470K , Lot Number 19ILA054 ; DYNJ0708470K , Lot Number 19JLA505 ; DYNJ0708470K , Lot Number 19KLA167 ; DYNJ0708470K , Lot Number 19LLA455 ; DYNJ0844004, Lot Number 19AKB795 ; DYNJ0844004, Lot Number 19DKC239 ; DYNJ0844004, Lot Number 19EKB799 ; DYNJ0844004, Lot Number 19FKB763 ; DYNJ0844004, Lot Number 19GKB309 ; DYNJ0844004, Lot Number 19HKC027 ; DYNJ0844004, Lot Number 19IKB582 ; DYNJ0844004, Lot Number 19JKB630 ; DYNJ0844004, Lot Number 19KKB713 ; DYNJ0934752F , Lot Number 20LLA127 ; DYNJ0934752F , Lot Number 21ALA602 ; DYNJ0934752F , Lot Number 21DLA714 ; DYNJ0934752F , Lot Number 21FLA405 ; DYNJ0934752F , Lot Number 21GLB256 ; DYNJ0934752F , Lot Number 21ILA246 ; DYNJ0934752F , Lot Number 21KLA976 ; DYNJ0934752F , Lot Number 22ALA019 ; DYNJ0934752F , Lot Number 22CLB255 ; DYNJ0934752F , Lot Number 22FLA066 ; DYNJ0934752F , Lot Number 22HLA808 ; DYNJ0934752F , Lot Number 23ALA905 ; DYNJ0934752F , Lot Number 23DLA487 ; DYNJ0934752F , Lot Number 23HLA233 ; DYNJ0934752F , Lot Number…
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-2625-2024
- Initiated
- April 8, 2024
- Posted by FDA
- August 27, 2024
- Product code
- OGE – Epidural 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-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-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 |