Recall Z-0087-2018 ยท OGE Epidural Anesthesia Kit
Epimed International
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
| Date | Jul 24, 2017 |
| Status | Terminated |
| Reason | Potential for partially incomplete seal of product, impacting sterility. |
| 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 | 500 units |
| Distribution | Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053318 | RX EPIDURAL NEEDLE Epimed International, Inc., Feb 17, 2006 |