Z-2642-2023Class II

Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous...

Name: Z-2642-2023 Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous...
Creator: Wolf, Henke Sass, Gmbh
Published: 2023-07-27
License: https://open.fda.gov/license/

Wolf, Henke Sass, GmbH / initiated 2023-07-27 / Open, Classified / root cause: packaging

FDA source

Wolf, Henke Sass, Gmbh began a recall of Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous and intraarterial injection of liquids... on 2023-07-27. FDA classified it as Class II and gives the reason as "Sterile barrier might be damaged compromising the sterility of the device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2642-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-27
Posted: 2023-09-27
Recalling firm: Wolf, Henke Sass, GmbH
Product: 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
Product code: FMF Syringe, Piston
Reason for recall: Sterile barrier might be damaged compromising the sterility of the device.
Root cause tag: packaging
FDA 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 [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.
Quantity in commerce: 216,000
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: UDI-DI: 04035873062004 and 04035873061991 Lot: 22M28C8 Lot: 23A09C8

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2642-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2642-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-04	2023-09-27

Product code FMF

K821537Class IIHenke Disposable SyringeC. B. Dumont Company, Inc. / cleared 1982-05-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)