Recall Z-2642-2023— Wolf, Henke Sass, Gmbh
Class II · Ongoing
Class II FDA medical device recall by Wolf, Henke Sass, Gmbh, initiated 2023-07-27. It names one FDA 510(k) clearance: K821537. 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. Reason: Sterile barrier might be damaged compromising the sterility of the device..
- Recalling firm
- Wolf, Henke Sass, Gmbh
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-27
- Firm location
- Tuttlingen, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Reason for recall
Sterile barrier might be damaged compromising the sterility of the device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.