Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous a
FDA device recall Z-2642-2023 · posted 2023-09-27 · Open, Classified
Recall details
- Recalling firm
- Wolf, Henke Sass, Gmbh
- Reason for recall
- Sterile barrier might be damaged compromising the sterility of the device.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FMF
- Quantity affected
- 216,000
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Date initiated
- 2023-07-27
- Date posted
- 2023-09-27
- Location
- Tuttlingen, Germany
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HENKE DISPOSABLE SYRINGE (K821537) | C. B. Dumont Company, Inc. | 1982-05-28 |