15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
This recall has been terminated (originally issued April 22, 2016).
- Company
- Epimed International, Inc.
- Recall Initiated
- April 22, 2016
- Terminated
- June 14, 2018
- Recall Number
- Z-0086-2017
- Quantity
- 576 units
- Firm Location
- Crossroads Business Park Johnstown, NY
- Official Source
- View on FDA website ↗
Reason for Recall
There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.
Distribution
US Distribution to the states of : AL, AK, FL, IN, TN & TX
Lot / Code Info
1) Spectra Lot# GC091702 (Epimed manufacturing lot # 2801501, Sterile Lot # 12157181) 2) Spectra Lot# GC101871 (Epimed manufacturing lot # 3211503, Sterile Lot # 12157445) 3) Spectra Lot# GC101897 (Epimed manufacturing lot # 3161501, Sterile Lot # 12157325)
Root Cause
Employee error
Action Taken
On April 22, 2016, Epimed sent an Urgent Medical Device Recall notices and Recall Return Response Forms to their customers via courier service. Customers were advised to examine all inventory and quarantine product subject to recall immediately. Once the product has been quarantined, please complete and return the enclosed response form as soon as possible by fax to: 518-725-0207, Attn: Quality Assurance. In addition, if you find any product that corresponds to the lot numbers given, please contact the Customer Service Department so that Epimed can arrange for replacement/credit (518-725-0209 or 518-514-1891). Further questions, please call (518) 725-0209.