MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010
FDA device recall Z-1937-2024 · posted 2024-05-31 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FMF
- Quantity affected
- 25,214,334 syringes
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama, UAE, USVI.
- Date initiated
- 2024-04-22
- Date posted
- 2024-05-31
- Location
- Northfield, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDLINE SYRINGES, MULTIPLE (K061275) | Medline Industries, Inc. | 2006-07-19 |