Device product
Diagnostic Imaging Tray (General Surgery convenience kit)
Z-0944-2015
Product summary
- Event
- Event 70081
- Status
- Terminated
- Classification
- Class II
- Quantity
- 760 kits
- Official record key
device-enforcement:Z-0944-2015
Official wording
Reason: According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.
Code information: CMP Kit code: MNS2955 Lot numbers: 2014061250 Expiration date: 2015-11
Distribution pattern: Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.
Derived failure modes
-
Foreign material or chemical contamination
particulate