Z-0772-2023 Class II Terminated
FDA device recall Z-0772-2023 was initiated by TELEFLEX LLC on Sep 28, 2022 and is designated Class II. Reason for recall: Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised. The recall status is terminated (terminated Jul 24, 2026). Affected quantity: 1,000 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 4, 2023
- Initiation Date
- Sep 28, 2022
- Termination Date
- Jul 24, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,000 units
Product Description
Pilling Wecksorb Cylindrical Sponges
Reason for Recall
Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.
Distribution Pattern
Domestic distribution to IL, MS, PA, TN.
Code Information
Catalog Number: 200400, Lot Number: 22B0395
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0772-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026