Z-0087-2018Class II

RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt...

Name: Z-0087-2018 RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt...
Creator: Epimed International
Published: 2017-07-24
License: https://open.fda.gov/license/

Epimed International, Inc. / initiated 2017-07-24 / Terminated / root cause: manufacturing process

FDA source

Epimed International began a recall of RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or... on 2017-07-24. FDA classified it as Class II and gives the reason as "Potential for partially incomplete seal of product, impacting sterility". 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-0087-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-24
Posted: 2017-11-09
Terminated: 2023-07-06
Recalling firm: Epimed International, Inc.
Product: RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter
Product code: OGE Epidural Anesthesia Kit
Reason for recall: Potential for partially incomplete seal of product, impacting sterility.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Consignees were contacted 07/24/2017 via email and phone, notifying them of the recall. Consignees were asked to contact the recalling firm to report the number of affected product on hand. A second, updated recall notification was sent on 08/04/2017. Instructions included to examine inventory and quarantine any affected product, contact Epimed to arrange return/credit of the affected product, and complete and return the response form.
Quantity in commerce: 500 units
Distribution: Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.
Product codes and lots: Lot No. 12168200; Ref No. 107-1416.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0087-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0087-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-15	2017-11-09
Z-0088-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-15	2017-11-09
Z-0089-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-15	2017-11-09

Product code OGE

K053318Class IIRx Epidural NeedleEpimed International, Inc. / cleared 2006-02-17

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)