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
FDA Recall Z-2642-2023 · Posted 2023-09-27
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Recalling FirmWolf, Henke Sass, Gmbh
Recall StatusOpen, Classified
Product CodeFMF
Date Initiated2023-07-27
Product Quantity216,000
Reason for Recall
Sterile barrier might be damaged compromising the sterility of the device.
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
[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.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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