Recall Z-1276-2021 ยท BSO Catheter, Conduction, Anesthetic
Epimed International, Inc.
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
| Date | Feb 1, 2021 |
| Status | Terminated |
| Reason | Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off |
| 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 |
| Quantity | 5835 units |
| Distribution | US Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954584 | RACZ EPIDURAL CATHETER Medic Evaluation Devices & Instruments Corp., Oct 8, 1996 |