FDA recall Z-1779-2022

Product

Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91

Reason for recall

The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle.

Distribution

Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.

Key facts

Status

Terminated

Initiation date

2022-09-08

Report date

2022-10-05

Termination date

2024-06-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Grand Rapids, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1779-2022