FDA Medical Device Recalls (openFDA)
Centurion Medical Products Corporation: Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)
- Recall number
- Z-0945-2015
- Recalling firm
- Centurion Medical Products Corporation
- Product
- Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)
- Status
- Terminated
- Initiated
- 2014-10-23
- Posted
- 2015-01-08
- Terminated
- 2015-06-08
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 8 kits
- Distribution
- Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.
- Lot, serial or model codes
- CMP Kit code: OR1955 Lot numbers: 2014061850 Expiration date: 2016-03
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OFA
- Firm FEI
- 3008403546
- Firm city
- Williamston
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28