Z-0086-2017Class II

15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or...

Name: Z-0086-2017 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or...
Creator: Epimed International, Inc.
Published: 2016-04-22
License: https://open.fda.gov/license/

Epimed International, Inc. / initiated 2016-04-22 / Terminated / root cause: manufacturing process

FDA source

Epimed International, Inc. began a recall of 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... on 2016-04-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0086-2017
Classification: Class II
Status: Terminated
Initiated: 2016-04-22
Posted: 2016-10-31
Terminated: 2018-06-14
Recalling firm: Epimed International, Inc.
Product: 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
Product code: BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
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.
Quantity in commerce: 576 units
Distribution: US Distribution to the states of : AL, AK, FL, IN, TN & TX
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0086-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0086-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-10-31

Product code BSP

K072005Class IIRk Epidural NeedleEpimed International / cleared 2008-02-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)