FDA Enforcement
Class II
Ongoing
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
Recall: Z-2642-2023
·
Reported October 4, 2023
Enforcement
- Recall Number
- Z-2642-2023
- Event ID
- 92836
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Wolf, Henke Sass, Gmbh
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- October 4, 2023
- Initiation Date
- July 27, 2023
- Classification Date
- September 27, 2023
- Address
- Kronenstrasse 16, N/A, Tuttlingen, N/A, N/A, Germany
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
Sterile barrier might be damaged compromising the sterility of the device.
Code Info
UDI-DI: 04035873062004 and 04035873061991 Lot: 22M28C8 Lot: 23A09C8
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Quantity
216,000