Centurion Diagnostic Imaging Tray Recalled for Human Hair Particulate
Centurion Medical Products is recalling 760 Diagnostic Imaging Trays due to a confirmed report of human hair embedded in a stopper.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a foreign object (human hair) in a single unit, which fits the criteria for a moderate risk without reported harm.
Plain-English summary
Centurion Medical Products Corporation is recalling 760 units of the Diagnostic Imaging Tray (General Surgery convenience kit). The recall was initiated after a confirmed customer report identified particulate matter in a single unit. The particulate was identified as human hair, which was embedded in and attached to a pinched area of the stopper.
The affected products are identified by CMP Kit code MNS2955, Lot number 2014061250, and an expiration date of 2015-11. The products were distributed nationwide, including to 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 or a refund.
The recalled product
- Product
- Diagnostic Imaging Tray (General Surgery convenience kit)
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 760
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: MNS2955 Lot numbers: 2014061250 Expiration date: 2015-11
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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