Centurion Medical Products Recalls Sterile Biopsy and Prep Packs Due to Seal Defects
Centurion Medical Products Corporation is recalling specific sterile medical packs and trays because incomplete 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 the hazard involves compromised sterility which poses a risk of harm (infection), fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Centurion Medical Products Corporation is recalling specific sterile medical products, including biopsy trays, latex tubing packs, and various prep packs. The recall is due to incomplete seals on the sterile packages, which may compromise the sterility of the contents.
The affected products were distributed nationwide and in Ghana. Specific lot numbers for the recalled items are listed in the official recall documentation.
Healthcare facilities and consumers should stop using these products and contact Centurion Medical Products Corporation for further instructions on returns or replacements.
The recalled product
- Product
- Centurion- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P261569 PACK BIOPSY P392929 BMT-LACERATION PACK P429589A TRAY BONE MARRO ASC LTX SAFE P734457 SUTURE REMOVAL PACK LATEX SAFE P751651A BIOPSY PROCEDURE PACK P758
- 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.
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