Centurion Pacemaker Tray Recalled Due to Human Hair Contamination
Centurion Medical Products is recalling 8 pacemaker trays because a customer reported human hair embedded in the stopper of a single unit.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a confirmed contamination (human hair) in a single unit, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Centurion Medical Products Corporation is recalling 8 units of the Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit). The recall was initiated after a confirmed customer report identified human hair embedded in and attached to a pinched area of the stopper in a single unit.
The affected kits are identified by CMP Kit code OR1955, Lot number 2014061850, and an expiration date of 2016-03. The products were distributed nationwide, including in Massachusetts, Indiana, New York, Georgia, Alabama, Pennsylvania, and Rhode Island.
Healthcare facilities and consumers should stop using the affected kits and contact Centurion Medical Products Corporation for further instructions.
The recalled product
- Product
- Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)
- Manufacturer
- Centurion Medical Products Corporation
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- CMP Kit code: OR1955 Lot numbers: 2014061850 Expiration date: 2016-03
Distribution
Part of a larger recall action
This product is one of 4 recalled by Centurion Medical Products Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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