Henke-Ject-2 part luer sterile single use syringes - used… recallZ-2642-2023 · Wolf, Henke Sass, Gmbh · initiated Jul 27, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Wolf, Henke Sass, Gmbh or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sterile barrier might be damaged compromising the sterility of the device.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2642-2023
- Status
- Open, Classified
- Initiated by the company
- Jul 27, 2023
- Posted by the FDA
- Sep 27, 2023
- Recalling firm
- Wolf, Henke Sass, Gmbh
- Quantity
- 216,000
- Product code
- FMF
- FDA submissions
- K821537
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
Product 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
Code information (models, lots, serial numbers)
UDI-DI: 04035873062004 and 04035873061991 Lot: 22M28C8 Lot: 23A09C8
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HSW HENKE-JECT® 4100.000V0Henke-Sass, Wolf GmbH · Syringe, Piston1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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