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Terminated

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

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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