Z-1276-2021Class II

Feth-R-Kath Catheter, 19g x 24"

Name: Z-1276-2021 Feth-R-Kath Catheter, 19g x 24"
Creator: Epimed International, Inc.
Published: 2021-02-01
License: https://open.fda.gov/license/

Epimed International, Inc. / initiated 2021-02-01 / Terminated / root cause: manufacturing process

FDA source

Epimed International, Inc. began a recall of Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement... on 2021-02-01. FDA classified it as Class II and gives the reason as "Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1276-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-01
Posted: 2021-03-18
Terminated: 2022-10-17
Recalling firm: Epimed International, Inc.
Product: Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less
Product code: BSO Catheter, Conduction, Anesthetic
Reason for recall: Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Epimed issued an " URGENT: MEDICAL DEVICE RECALL" letter on 2/1/21via US Mail. Letter states reason for recall, health risk and Actions to be taken by the Customer/User: " Immediately examine your inventory and quarantine product subject to recall. o In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. " Your notification to your customers may be enhanced by including a copy of this recall notification letter. " Once the product has been quarantined, please complete the Recall Response Form in its entirety- indicating product quantity/disposition, and return the enclosed response form as soon as possible. Epimed Contact Information: In addition, please contact our Sales Administrative Assistant, Bobbi Harrington at (518) 848-3914 or [email protected], so that we can arrange for replacement or credit of the affected product. Contact hours are from 6:00am - 4:00pm EST.
Quantity in commerce: 5835 units
Distribution: US Nationwide distribution
Product codes and lots: Lot Numbers: 11247915, 11248510, 11248553, 11248938, 11248985, 11249049

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1276-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1276-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-18

Product code BSO

K954584Class IIRacz Epidural CatheterMedic Evaluation Devices & Instruments Corp. / cleared 1996-10-08

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)