FDA recall Z-0199-2023

Product

Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter

Reason for recall

Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.

Distribution

Domestic distribution to NC, RI, NJ, and IL. No foreign distribution.

Key facts

Status

Terminated

Initiation date

2021-02-24

Report date

2022-11-16

Termination date

2024-05-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0199-2023