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Terminated

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

FDA Recall Z-0087-2018 · Posted None

Recalling FirmEpimed International
Recall StatusTerminated
Product CodeOGE
Date Initiated2017-07-24
Date Terminated2023-07-06
Product Quantity500 units

Reason for Recall

Potential for partially incomplete seal of product, impacting sterility.

Firm 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.

Root Cause

Employee error

Distribution Pattern

Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053318RX EPIDURAL NEEDLEEpimed International, Inc. · 2006-02-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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