Recall Z-0942-2015
Centurion Medical Products Corporation · initiated October 23, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit)
Codes / lots: CMP Kit code: CHT900 Lot numbers: 2014061950 and 2014070750 Expiration date, both lots: 2016-03
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
Centurion sent an Urgent Product Recall Notice dated October 23, 2014, to al affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and remove all affected inventory that may be in their possession and to forward a copy of thie noctice to any cusotmers to whom the affected product may have been further distributed. Customers were asked to complete the enclosed accountability record whether not they have the product and fax to 517-546-3356. Customers with questions were instructed to call 517-546-5400 Ext. 1135. For questions regarding this recall call 517-546-5400, ext 1135.
Details
- Recall number
- Z-0942-2015
- Initiated
- October 23, 2014
- Posted by FDA
- January 8, 2015
- Terminated
- June 8, 2015
- Product code
- OFA – Cardiovascular Surgical Instruments Tray
- Quantity
- 42 kits
- Distribution
- Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.
- Recalling firm
- Centurion Medical Products Corporation, Williamston, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0943-2015 Class II | Nerve Block Tray (Nerve Block convenience kit)According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer… | 10/23/2014Terminated |
| Z-0944-2015 Class II | Diagnostic Imaging Tray (General Surgery convenience kit)According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer… | 10/23/2014Terminated |
| Z-0945-2015 Class II | Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer… | 10/23/2014Terminated |