Device product
COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile
Z-0088-2018
Product summary
- Event
- Event 77842
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 units
- Official record key
device-enforcement:Z-0088-2018
Official wording
Reason: Potential for partially incomplete seal of product, impacting sterility.
Code information: Lot No. 12608201; Ref No. 117-2260.
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