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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
See all 4 products in this recall →Related recalls
Same manufacturer · Centurion Medical Products Corporation
See all →- HighCenturion Difficult IV Kit Recalled for False Carboxyhemoglobin Results
FDA (Devices) · 2020-07-15
- HighCenturion ENT Snuffer Kit Recalled for Incomplete Sterile Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Chest Tube Trays Recalled for Incomplete Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Pitcher Kits Due to Seal Defects
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Hyperalimentation and Dressing Change Trays
FDA (Devices) · 2020-02-12
Same hazard · foreign object contamination
See all →- HighCelecoxib Capsules Recalled for Foreign Tablet Contamination
FDA (Drugs) · 2025-06-18
- LowLevothyroxine Sodium tablets recalled for foreign substance contamination
FDA (Drugs) · 2025-06-18
- HighSalsa Cilantro recalled for potential foreign object contamination
FDA (Food) · 2025-06-11
- SevereTestosterone Pellet 200 mg Recalled Due to Glass Particles
FDA (Drugs) · 2025-05-14
- HighEllington Farms Lemonade Drink Mix recalled for metal fragment contamination
FDA (Food) · 2024-12-11
Similar recalls
- HighCenturion Medical Recalls Circumcision Kits Due to Sterile Packaging Concerns
FDA (Devices) · 2019-08-14
- HighCenturion Laceration Tray Kits Recalled for Potential Sterile Packaging Compromise
FDA (Devices) · 2019-08-14
- HighCenturion Medical Recalls Circumcision Trays Due to Sterile Packaging Concerns
FDA (Devices) · 2019-08-14
- HighCenturion Medical Recalls Driveline Management Tray Kits Due to Packaging Risk
FDA (Devices) · 2019-08-14
- HighCenturion Neonatal PICC Insertion Tray Recalled for Packaging Compromise
FDA (Devices) · 2019-08-14
- HighCenturion Medical Recalls Suture Trays Due to Sterile Packaging Concerns
FDA (Devices) · 2019-08-14