Z-1851-2016 Class II Terminated
FDA device recall Z-1851-2016 was initiated by Covidien LLC on Mar 3, 2016 and is designated Class II. Reason for recall: Compromised sterility due to breach of barrier The recall status is terminated (terminated Jun 15, 2017). Affected quantity: 28085.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 8, 2016
- Initiation Date
- Mar 3, 2016
- Termination Date
- Jun 15, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28085
Product Description
Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item Number: 4037
Reason for Recall
Compromised sterility due to breach of barrier
Distribution Pattern
Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.
Code Information
All lots beginning with 110000311262 through lot 15G162262X
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1851-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026