CLASS II Device recall · Reported 14 Jan 2015 · FDA Enforcement Report

Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit) recalled

Centurion Medical Products is recalling Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit), distributed nationwide in the US. The recall was initiated on 23 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCMP Kit code: OR1955 Lot numbers: 2014061850 Expiration date: 2016-03

Quantity recalled8 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0945-2015
FDA event ID: 70081
Recalling firm: Centurion Medical Products, Williamston, MI
Classification: Class II
Status: Terminated
Recall initiated: 23 Oct 2014
FDA classified: 8 Jan 2015
Reported: 14 Jan 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Pacemakers & Defibrillators

Timeline

23 Oct 2014	Recall initiated by company
8 Jan 2015	Classified by FDA	+77 days
14 Jan 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)

Where it was distributed

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

Nationwide Alabama Georgia Indiana Massachusetts New York Pennsylvania Rhode Island

Questions about this recall

Why was it recalled?

Which lots are affected?

CMP Kit code: OR1955 Lot numbers: 2014061850 Expiration date: 2016-03

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 70081

This product is part of a recall event; the main page for the event is Diagnostic Imaging Tray (General Surgery convenience kit) recalled.

Reported	Class	Recall	Company	Reason	Where
14 Jan 2015	CLASS II	Diagnostic Imaging Tray (General Surgery convenience kit) recalled	Centurion Medical Products	Particulate Matter	Nationwide
14 Jan 2015	CLASS II	Chest Tube Tray (Cardiovascular Surgical Instruments recalled	Centurion Medical Products	Particulate Matter	Nationwide
14 Jan 2015	CLASS II	Nerve Block Tray (Nerve Block convenience kit) recalled	Centurion Medical Products	Particulate Matter	Nationwide

More recalls from Centurion Medical Products

All 152

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