Z-2313-2021Class II

NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile

Name: Z-2313-2021 NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Creator: Epimed International
Published: 2017-12-28
License: https://open.fda.gov/license/

Epimed International, Inc. / initiated 2017-12-28 / Completed / root cause: manufacturing process

FDA source

Epimed International began a recall of NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile on 2017-12-28. FDA classified it as Class II and gives the reason as "Potential for stylet to protrude from the distal end of the catheter". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2313-2021
Classification: Class II
Status: Completed
Initiated: 2017-12-28
Posted: 2021-08-18
Recalling firm: Epimed International, Inc.
Product: NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Product code: BSO Catheter, Conduction, Anesthetic
Reason for recall: Potential for stylet to protrude from the distal end of the catheter
Root cause tag: manufacturing process
FDA 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 in commerce: 140 units
Distribution: Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.
Product codes and lots: Reference Number 201-2430, Lot Numbers 16308139 (Expiration August 2022), 16308383 (Expiration October 2022)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2313-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2312-2021	Class II	Completed	Voluntary: Firm initiated	2021-08-25	2021-08-18
Z-2313-2021	Class II	Completed	Voluntary: Firm initiated	2021-08-25	2021-08-18

Product code BSO

K981329Class IIFeth-R-KathEpimed International, Inc. / cleared 1998-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)