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
This recall is currently active, issued September 27, 2023. It was issued by Wolf, Henke Sass, Gmbh Kronenstrasse 16 Tuttlingen Germany.
- Recall Initiated
- July 27, 2023
- Posted
- September 27, 2023
- Recall Number
- Z-2642-2023
- Quantity
- 216,000
- Official Source
- View on FDA website ↗
Reason for Recall
Sterile barrier might be damaged compromising the sterility of the device.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Lot / Code Info
UDI-DI: 04035873062004 and 04035873061991 Lot: 22M28C8 Lot: 23A09C8
Root Cause
Under Investigation by firm
Action Taken
Henke-Sass, Wolf GmbH notified the US Distributor on 7/24/24 via email and telecon. US Distributor notified their consignees (Distributors)via phone/ email on July 27, 2023. Letter states reason for recall, health risk and action to take: 1. Immediately remove any of these items with these lot numbers from active inventory. 2. Whether you do or do not have any of the items remaining in inventory, please complete the attached response form and return to atinfo@air-tite.com. 3. If you have inventory remaining, you will receive instructions and a return label once we have received your completed form. 4. If you have sent this product to another customer, forward this information, or collect the information and submit a response on their behalf. 5. If you have imported or distributed these products in Canada, please note that Health Canada has been notified and you may have specific additional obligations. If you have any questions or concerns, please contact us, atinfo@air-tite.com, (800) 231-7762.