Centurion Medical Products Recalls Sterile Surgical Trays Due to Seal Defects
Centurion Medical Products is recalling various sterile surgical trays and packs 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 involves a risk-of-harm product (sterile medical devices) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Centurion Medical Products Corporation is recalling specific lots of sterile medical devices, including general surgery trays, radiology cut down trays, circumcision packs, and sterile barrier kits. The recall is being conducted because incomplete seals on the sterile packages may compromise the sterility of the contents.
The affected products were distributed nationwide and in Ghana. The recall covers specific lot numbers for items such as the DYNDA1127A Radiology Cut Down Tray, DYNDA1178 ICIO Tray, and DYNDA1349A Circumcision Tray, among others. The source text does not specify the total number of units affected or report any illnesses or injuries associated with the use of these products.
Healthcare facilities and consumers should stop using the affected products and contact Centurion Medical Products Corporation for further instructions on how to return or dispose of the items.
The recalled product
- Product
- Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO TRAY DYNDA1183 AUXILARY TOWEL PACK DYNDA1223 CUSTOM PREP CUP KIT DYNDA1223 CUSTOM PREP CUP KIT DYNDA1246A CIRCUMCISION PACK DYNDA1349A CIRCUMCISION TRAY DYNDA1388 STERILE EK DOUBLE PACK
- 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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