Centurion Medical Products Recalls Biopsy Trays Due to Incomplete Seals
Centurion Medical Products is recalling specific biopsy trays because incomplete sterile package seals may compromise sterility.
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 is classified as FDA Class II and involves a risk-of-harm product (compromised sterility) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling specific lots of biopsy trays, including the BT205A Minor Set Up Biopsy Tray and the BT345A HH Pack Biopsy. The recall is due to incomplete seals on the sterile packages, which may compromise the sterility of the medical devices.
The affected products were distributed nationwide and in Ghana. The specific lot numbers involved are 2019012490 for the BT205A and 2019040590 and 2019021290 for the BT345A. The FDA has classified this as a Class II recall.
Healthcare providers and consumers should stop using these specific lots of biopsy trays and contact Centurion Medical Products Corporation for instructions on how to return or dispose of the products.
The recalled product
- Product
- Centurion-BIOPSY TRAY BT205A MINOR SET UP BIOPSY TRAY BT345A HH PACK BIOPSY
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Trays
- Hazard
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)
- 2019021290
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.
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