Z-2312-2021 Class II
FDA device recall Z-2312-2021 was initiated by Epimed International on December 28, 2017 and is designated Class II. Reason for recall: Potential for stylet to protrude from the distal end of the catheter Affected quantity: 132 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 25, 2021
- Initiation Date
- December 28, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 132 units
Product Description
NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
Reason for Recall
Potential for stylet to protrude from the distal end of the catheter
Distribution Pattern
Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.
Code Information
Reference Number 200-2430, Lot Numbers 16308275 (Expiration August 2022), 16308382 (Expiration October 2022)