Centurion Biopsy Tray Recalled Due to Incomplete Sterile Package Seals
Centurion Medical Products is recalling 60 Biopsy Trays because incomplete seals on the sterile package may compromise sterility.
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 is classified as FDA Class II. The hazard involves a potential compromise of sterility, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Centurion Medical Products Corporation is recalling 60 units of the Centurion Biopsy Tray (TRIBT170). The recall was initiated because incomplete seals on the sterile package may compromise the sterility of the product.
The affected products were distributed nationwide and to Ghana. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and consumers should stop using the affected Biopsy Trays and contact Centurion Medical Products Corporation for further instructions.
The recalled product
- Product
- Centurion- Biopsy Tray TRIBT170 BIOPSY TRAY
- Manufacturer
- Centurion Medical Products Corporation
- Hazard
- Affected units
- 60
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)
- TRIBT170 BIOPSY TRAY 2019052490
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 54 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 54 products in this recall →Related recalls
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