Recall Z-1276-2021
Epimed International, Inc. · initiated February 1, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot Numbers: 11247915, 11248510, 11248553, 11248938, 11248985, 11249049
Reason for recall
Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
FDA-determined cause: Process control
Action taken
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 bobbih@epimed.com, so that we can arrange for replacement or credit of the affected product. Contact hours are from 6:00am - 4:00pm EST.
Details
- Recall number
- Z-1276-2021
- Initiated
- February 1, 2021
- Terminated
- October 17, 2022
- Product code
- BSO – Catheter, Conduction, Anesthetic
- Quantity
- 5835 units
- Distribution
- US Nationwide distribution
- Recalling firm
- Epimed International, Inc., Johnstown, NY