Device product
NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
Z-2312-2021
Product summary
- Event
- Event 88317
- Status
- Completed
- Classification
- Class II
- Quantity
- 132 units
- Official record key
device-enforcement:Z-2312-2021
Official wording
Reason: Potential for stylet to protrude from the distal end of the catheter
Code information: Reference Number 200-2430, Lot Numbers 16308275 (Expiration August 2022), 16308382 (Expiration October 2022)
Distribution pattern: Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.
Derived failure modes
-
Unknown
Potential for stylet to protrude from the distal end of the catheter