Recall Z-1938-2024
MEDLINE INDUSTRIES, LP - Northfield · initiated April 22, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
Codes / lots: UDI/DI 10080196306183, All lots in the format: 897YYMMXXXX
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.
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-1938-2024
- Initiated
- April 22, 2024
- Posted by FDA
- May 31, 2024
- Product code
- FMF – Syringe, Piston
- Quantity
- 5,075,234 syringes
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama, UAE, USVI.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1937-2024 Class II | MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010It has been identified that testing documentation does not support that the syringes can successfully… | 04/22/2024Open, Classified |