Device product
Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.
Z-0229-2016
Product summary
- Event
- Event 72053
- Status
- Terminated
- Classification
- Class II
- Quantity
- 255 packs
- Official record key
device-enforcement:Z-0229-2016
Official wording
Reason: The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.
Code information: Lot 25787E, exp. date 1/19/2017
Distribution pattern: Product was distributed to one customer in Oklahoma.
Derived failure modes
-
Unknown
The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.