Z-0358-2020 Class II Ongoing
FDA device recall Z-0358-2020 was initiated by TriMed Inc. on September 28, 2018 and is designated Class II. Reason for recall: The spring on the PEG-Extender can rust due to the type of steel used to manufacture it. The recall status is ongoing. Affected quantity: 1,903 Peg Guide Extenders.
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- September 28, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,903 Peg Guide Extenders
Product Description
TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Reason for Recall
The spring on the PEG-Extender can rust due to the type of steel used to manufacture it.
Distribution Pattern
Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
Code Information
Lot number 2858, 2861, and 3749