FDA recall Z-2642-2023

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 for recall

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

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status

Ongoing

Initiation date

2023-07-27

Report date

2023-10-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tuttlingen, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2642-2023