Device product
Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit)
Z-0942-2015
Product summary
- Event
- Event 70081
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42 kits
- Official record key
device-enforcement:Z-0942-2015
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: CHT900 Lot numbers: 2014061950 and 2014070750 Expiration date, both lots: 2016-03
Distribution pattern: Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.
Derived failure modes
-
Foreign material or chemical contamination
particulate