FDAClass IIJanuary 14, 2015

Pacemaker Tray recall: Particulate Matter

Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)

Why was Pacemaker Tray 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)
Recalling firm
Centurion Medical Products Corporation
Quantity
8 kits
Distribution
Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.
Recall date
January 14, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls