Z-0227-2023 Class II Ongoing
FDA device recall Z-0227-2023 was initiated by TELEFLEX LLC on Sep 20, 2022 and is designated Class II. Reason for recall: Product may not be sterile The recall status is ongoing. Affected quantity: 7200 catheters.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 23, 2022
- Initiation Date
- Sep 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7200 catheters
Product Description
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 Pattern
TN, CA, NC, TX, FL, OH, MO, IL, OR
Code Information
UDI (01)24026704323245(17)250405(10)74E2200810
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0227-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026