Device product
Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous and intraarterial injection of liquids or diluted drugs in combination with an adequate medical device or for withdrawal of fluids from the body. Ref: 4100.000V0
Z-2642-2023
Product summary
- Event
- Event 92836
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 216,000
- Official record key
device-enforcement:Z-2642-2023
Official wording
Reason: Sterile barrier might be damaged compromising the sterility of the device.
Code information: UDI-DI: 04035873062004 and 04035873061991 Lot: 22M28C8 Lot: 23A09C8
Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.
Derived failure modes
-
Unknown
Sterile barrier might be damaged compromising the sterility of the device.