Recall Z-1936-2024 ยท FMF Syringe, Piston
MEDLINE INDUSTRIES, LP - Northfield
Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW PR, Item Number: DYNJSYRPP20B; c) SYRINGE 20ML RED L/L LOW PRESS, Item Number: DYNJSYRPP20R; d) SYRINGE 10ML RED L/L LOW PR, Item Number: DYNJSYRPP10R; e) SYRINGE 10ML GREEN L/L LOW PR, Item Number: DYNJSYRPP10G; f) SYRINGE 10ML WHITE L/L LOW PR, Item Number: DY
| Date | May 31, 2024 (initiated Apr 17, 2024) |
| Status | Open, Classified |
| Reason | These syringes were identified to be 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. |
| Root cause | Under Investigation by firm |
| Action | Medline Industries, LP issued a recall notice to its consignees on 04/17/2024 via USPS, First Class mail. The notice explained the issue, potential risk to the user, and requested the consignee destroy all affected product. If the product was further distributed, the party distributing the affected product was directed to notify their customers. |
| Quantity | 2,348,430 syringes |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.