Device product
TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
Z-0410-2018
Product summary
- Event
- Event 78349
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0410-2018
Official wording
Reason: There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile.
Code information: Lot numbers: 47883, 47910 & 47911
Distribution pattern: NY - Only one US distributor
Derived failure modes
-
Sterility assurance
packaging material which can compromise the devices sterility, making it non-sterile