FDA Device recall Z-2642-2023
Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous and intraarterial in…
- FDA Device
- Class II
- ongoing
- Published 2023-10-04
On 2023-10-04 the FDA classified a Class II recall of Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous and intraarterial in… by Wolf Henke Sass, citing sterile barrier might be damaged compromising the sterility of the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2642-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-27 |
| Published | 2023-10-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Wolf Henke Sass |
| Distribution | US |
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.
Identifiers
| code_info | UDI-DI: 04035873062004 and 04035873061991 Lot: 22M28C8 Lot: 23A09C8 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2642-2023%22
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