Z-1276-2021 Class II Terminated
FDA device recall Z-1276-2021 was initiated by Epimed International, Inc. on February 1, 2021 and is designated Class II. Reason for recall: Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off The recall status is terminated (terminated October 17, 2022). Affected quantity: 5835 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 24, 2021
- Initiation Date
- February 1, 2021
- Termination Date
- October 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5835 units
Product Description
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
Reason for Recall
Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
Distribution Pattern
US Nationwide distribution
Code Information
Lot Numbers: 11247915, 11248510, 11248553, 11248938, 11248985, 11249049