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
Product summary
- 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
incomplete seal