Henke-Ject-2 Sterile Syringes Recalled for Potential Sterile Barrier Damage
Wolf, Henke Sass is recalling Henke-Ject-2 single-use sterile syringes due to potential damage to the sterile barrier that could compromise product sterility. Approximately 216,000 units are affected across the US and Canada.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device recall. Sterile barrier damage poses risk to device sterility. No illnesses or injuries reported. Meets rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Wolf, Henke Sass is recalling Henke-Ject-2 part luer sterile single-use syringes (UDI-DI: 04035873062004 and 04035873061991, Lots 22M28C8 and 23A09C8) because the sterile barrier may be damaged, potentially compromising the sterility of the device. These syringes are used for intravenous, intramuscular, subcutaneous, intracutaneous, and intraarterial injection of liquids or diluted drugs, and for withdrawal of fluids from the body.
Approximately 216,000 units have been distributed worldwide, including throughout the United States and Canada. Healthcare providers and patients who have syringes from the affected lots should consult with their healthcare provider regarding their use.
The recalled product
- 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: 4100.00
- Manufacturer
- Wolf, Henke Sass, Gmbh
- Category
- Medical Device — Syringes
- Hazard
- sterile-barrier-damage
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04035873062004 and 04035873061991 Lot: 22M28C8 Lot: 23A09C8
Distribution
Distributed nationwide across the United States.
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