FDAClass IIOctober 4, 2023

Henke-Ject-2 recall: Sterility Concern

Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous and intraarterial injection of…

Why was Henke-Ject-2 recalled?

Sterile barrier might be damaged compromising the sterility of the device.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 04035873062004 and 04035873061991 Lot: 22M28C8 Lot: 23A09C8

Product
Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous and intraarterial injection of…
Recalling firm
Wolf, Henke Sass, Gmbh
Quantity
216,000
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Recall date
October 4, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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