Device product

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

Z-0227-2023

September 20, 2022

Class II

Product summary

Firm: TELEFLEX LLC
Event: Event 90962
Status: Ongoing
Classification: Class II
Quantity: 7200 catheters
Official record key: device-enforcement:Z-0227-2023

Official wording

Reason: Product may not be sterile

Code information: UDI (01)24026704323245(17)250405(10)74E2200810

Distribution pattern: TN, CA, NC, TX, FL, OH, MO, IL, OR

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Product may not be sterile