Recall Z-2632-2024
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) NEURO ANGIO PACK, Part Number DYNDA1431A; 2) CVC INSERT BUNDLE 16CM, Part Number ECVC3260; 3) CENTRAL LINE INSERTION KIT, Part Number ECVC7440; 4) CENTRAL LINE INSERTION KIT, Part Number ECVC7445; 5) CENTRAL LINE INSERTION KIT W/20CM CATH, Part Number ECVC7445A; 6) VANTEX 7FR 3L 20CM CVC BUNDLE US, Part Number ECVC8045; 7) CVC DOUBLE LUMEN 16CM, Part Number ECVC8105
Codes / lots: DYNDA1431A, Lot Number 2019021190; ECVC3260, Lot Number 2019091850; ECVC3260, Lot Number 2019120950; ECVC7440, Lot Number 2021071950; ECVC7440, Lot Number 2021092150; ECVC7445, Lot Number 2021052850; ECVC7445, Lot Number 2021062250; ECVC7445A, Lot Number 2022012850; ECVC7445A, Lot Number 2023010390; ECVC8045, Lot Number 2023031590; ECVC8105, Lot Number 2023112190
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-2632-2024
- Initiated
- April 8, 2024
- Posted by FDA
- August 27, 2024
- Product code
- LRP – Tray, Surgical
- 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-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-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 |