Recall Z-2642-2023 ยท FMF Syringe, Piston
Wolf, Henke Sass, Gmbh
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
| Date | Sep 27, 2023 (initiated Jul 27, 2023) |
| Status | Open, Classified |
| Reason | Sterile barrier might be damaged compromising the sterility of the device. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 216,000 |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K821537 | HENKE DISPOSABLE SYRINGE C. B. Dumont Company, Inc., May 28, 1982 |