Z-2642-2023 Class II Ongoing

Recalled by Wolf, Henke Sass, Gmbh — Tuttlingen, N/A

Recall Details

Product Type
Devices
Report Date
October 4, 2023
Initiation Date
July 27, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
216,000

Product Description

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

Reason for Recall

Sterile barrier might be damaged compromising the sterility of the device.

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Code Information

UDI-DI: 04035873062004 and 04035873061991 Lot: 22M28C8 Lot: 23A09C8