FDA Device recall Z-2312-2021
NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
- FDA Device
- Class II
- completed
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile by Epimed International, citing potential for stylet to protrude from the distal end of the catheter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2312-2021 |
| Classification | Class II |
| Status | completed |
| Initiated | 2017-12-28 |
| Published | 2021-08-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Epimed International |
| Distribution | CA, DE, OH, OK, PA, VA, WA, WV |
Product
NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
Reason
Potential for stylet to protrude from the distal end of the catheter
Identifiers
| code_info | Reference Number 200-2430, Lot Numbers 16308275 (Expiration August 2022), 16308382 (Expiration October 2022) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2312-2021%22
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