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
FDA Recall Z-0086-2017 · Posted None
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Recalling FirmEpimed International, Inc.
Recall StatusTerminated
Product CodeBSP
Date Initiated2016-04-22
Date Terminated2018-06-14
Product Quantity576 units
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.
Firm Action
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.
Root Cause
Employee error
Distribution Pattern
US Distribution to the states of : AL, AK, FL, IN, TN & TX
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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