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Recall Observatory FDA recall evidence

Device 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

Z-0087-2018

July 24, 2017

Class II

Product summary

Firm
Epimed International
Event
Event 77842
Status
Terminated
Classification
Class II
Quantity
500 units
Official record key
device-enforcement:Z-0087-2018

Official wording

Reason: Potential for partially incomplete seal of product, impacting sterility.

Code information: Lot No. 12168200; Ref No. 107-1416.

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incomplete seal