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
Recall
- Recall Number
- Z-2642-2023
- Event Number
- 92836
- Firm
- Wolf, Henke Sass, Gmbh Kronenstrasse 16 Tuttlingen Germany
- FEI Number
- 3002807224
- Product Code
- FMF
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- July 27, 2023
- Posted
- September 27, 2023
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
Sterile barrier might be damaged compromising the sterility of the device.
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 [email protected]. 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, [email protected], (800) 231-7762.
Worldwide distribution - US Nationwide and the country of Canada.
216,000