Recall Z-1937-2024 ยท FMF Syringe, Piston
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010
| Date | May 31, 2024 (initiated Apr 22, 2024) |
| Status | Open, Classified |
| Reason | It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and 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 04/22/2024 via USPS first class mail. The notice explained the problem with the device, potential risk, and requested that the affected product be destroyed. |
| Quantity | 25,214,334 syringes |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Panama, UAE, USVI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061275 | MEDLINE SYRINGES, MULTIPLE Medline Industries, Inc., Jul 19, 2006 |