Device product
MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010
Z-1937-2024
Product summary
- Event
- Event 94537
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 25,214,334 syringes
- Official record key
device-enforcement:Z-1937-2024
Official wording
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.
Code information: UDI/DI 10884389596319, All lots in the format: 897YYMMXXXX
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Panama, UAE, USVI.
Derived failure modes
-
Unknown
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.