Centurion Medical Products Recalls Sterile Biopsy and Arthrogram Trays
Centurion Medical Products is recalling specific sterile biopsy and arthrogram trays due to incomplete seals that 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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential sterility compromise.
Plain-English summary
Centurion Medical Products Corporation is recalling specific sterile medical trays, including arthrogram trays, biopsy trays, and cyst aspiration trays. The recall is due to incomplete seals on the sterile packages, which may compromise the sterility of the contents.
The affected products include various specifications such as SPEC0002B, SPEC0004C, SPEC0071B, SPEC0076G, SPEC0122, SPEC0130B, SPEC0158A, SPEC0248B, SPEC0265A, and SPEC0313. Specific lot numbers are listed in the agency's recall record. The products were distributed nationwide and to Ghana.
Healthcare facilities and consumers should stop using these products and contact Centurion Medical Products Corporation for further instructions or a refund.
The recalled product
- Product
- Centurion- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C ARTHROGRAM TRAY SPEC0071B CUSTOM BX TRAY SPEC0076G STEREO BIOPSY PACK-LF SPEC0122 BASIC BIOPSY TRAY SPEC0130B BREAST BIOPSY TRAY SPEC0158A CT BIOPSY TRAY SPEC0248B GENERAL BIOPSY TRAY- LF…
- Manufacturer
- Centurion Medical Products Corporation
- Hazard
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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