Z-2601-2018 Class II Terminated
FDA device recall Z-2601-2018 was initiated by Covidien LLC on Jun 15, 2018 and is designated Class II. Reason for recall: Potential proplylene glycol contamination The recall status is terminated (terminated May 8, 2019). Affected quantity: 972 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 8, 2018
- Initiation Date
- Jun 15, 2018
- Termination Date
- May 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 972 units
Product Description
Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
Reason for Recall
Potential proplylene glycol contamination
Distribution Pattern
CA, NY & TX
Code Information
UDI - 10884521043718 /20884521043715 Lot Number - A8C0783X
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2601-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026