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
FDA Recall Z-1276-2021 · Posted None
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Recalling FirmEpimed International, Inc.
Recall StatusTerminated
Product CodeBSO
Date Initiated2021-02-01
Date Terminated2022-10-17
Product Quantity5835 units
Reason for Recall
Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
Firm 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.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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