Centurion Medical Products Recalls Surgical Trays Due to Incomplete Seals
Centurion Medical Products is recalling various surgical trays and kits because incomplete seals on the sterile packages 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, and the hazard involves compromised sterility of medical devices, which presents a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling a wide range of surgical trays, kits, and instrument sets, including delivery trays, biopsy kits, and nasal hemorrhage sets. 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 FDA recall record Z-1054-2020.
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-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY TRAY MNS10310 MEATOTOMY TRAY MNS10525 DELIVERY INSTRUMENT TRAY MNS10620 PACEMAKER TRAY MNS10820 ENT/EPISTAXIS KIT MNS10920 PODIATRY NAIL PACK MNS10985 CERCLAGE REMOVAL KIT MNS11020…
- 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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