Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)

FDA device recall Z-0945-2015 · posted 2015-01-08 · Terminated

Recall details

Recalling firm

Centurion Medical Products Corporation

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.

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

OFA

Quantity affected

8 kits

Distribution

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

Date initiated

2014-10-23

Date posted

2015-01-08

Date terminated

2015-06-08

Location

Williamston, MI