Device product
TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
Z-0089-2018
Product summary
- Event
- Event 77842
- Status
- Terminated
- Classification
- Class II
- Quantity
- 263 units
- Official record key
device-enforcement:Z-0089-2018
Official wording
Reason: Potential for partially incomplete seal of product, impacting sterility.
Code information: Lot No. 12358202; Ref No. 125-2035T.
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