FDA recall Z-0227-2023

Product

Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.

Reason for recall

Product may not be sterile

Distribution

TN, CA, NC, TX, FL, OH, MO, IL, OR

Key facts

Status

Ongoing

Initiation date

2022-09-20

Report date

2022-11-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0227-2023