Z-0945-2015Class II

Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)

Name: Z-0945-2015 Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)
Creator: Centurion Medical Products Corporation
Published: 2014-10-23
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2014-10-23 / Terminated / root cause: manufacturing process

FDA source

Centurion Medical Products Corporation began a recall of Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit) on 2014-10-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0945-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-23
Posted: 2015-01-08
Terminated: 2015-06-08
Recalling firm: Centurion Medical Products, LP
Product: Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)
Product code: OFA Cardiovascular Surgical Instruments Tray
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 8 kits
Distribution: Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.
Product codes and lots: CMP Kit code: OR1955 Lot numbers: 2014061850 Expiration date: 2016-03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0945-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0942-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-08
Z-0943-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-08
Z-0944-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-08
Z-0945-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-08

Product code OFA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)