—#132231

Product

Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit)

FDA product code: OFA — Cardiovascular Surgical Instruments Tray
Device class: Class 1
Medical specialty: Cardiovascular
Affected lot / code info: CMP Kit code: CHT900 Lot numbers: 2014061950 and 2014070750 Expiration date, both lots: 2016-03

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Centurion Medical Products Corporation
Address: 100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern: Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.

Timeline

Recall initiated: 2014-10-23
Posted by FDA: 2015-01-08
Terminated: 2015-06-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132231. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.