FDA Medical Device Recalls (openFDA)
Epimed International: NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
- Recall number
- Z-2313-2021
- Recalling firm
- Epimed International
- Product
- NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
- Status
- Completed
- Initiated
- 2017-12-28
- Posted
- not on file
- Terminated
- not on file
- Reason
- Potential for stylet to protrude from the distal end of the catheter
- Root cause
- Process control
- Action
- On about 12/28/2017, Epimed mailed their recall notification letter titled, URGENT Medical Device RECALL, to customers. Those letters were followed up with a telephone call or email containing the letter on about 12/30/2017. The letter explained the issue and hazard and requested that if any potentially affected product remains in the accounts inventory, Epimed will offer to replace/credit the affected product. Each customer was asked to complete and return the RECALL RETURN RESPONSE FORM as soon as possible.
- Quantity
- 140 units
- Distribution
- Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.
- Lot, serial or model codes
- Reference Number 201-2430, Lot Numbers 16308139 (Expiration August 2022), 16308383 (Expiration October 2022)
- 510(k) numbers
- ["K981329"]
- PMA numbers
- not on file
- Product code
- BSO
- Firm FEI
- 1643059
- Firm city
- Farmers Branch
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28