Customed Recalls Open Heart Surgical Trays Due to Packaging Integrity Concerns
Customed, Inc. is recalling Open Heart Surgical Trays because packaging integrity may be compromised, potentially leading to product contamination or loss of 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 surgical supplies) where injury has not yet been reported, fitting the 'High' severity criteria for potential contamination or loss of sterility.
Plain-English summary
Customed, Inc. is recalling specific lots of Open Heart Surgical Trays (Pack A and Pack B) due to a potential compromise in packaging integrity. The recall involves 6 lots totaling 127 units. The affected products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
The recall was initiated because the compromised packaging could result in product contamination or a loss of sterility condition. This poses a risk of injury to patients if the non-sterile or contaminated products are used during surgical procedures.
The affected lots were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and USVI) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Healthcare facilities and consumers who have these specific lot numbers should stop using the products and contact Customed, Inc. for instructions on return or replacement.
The recalled product
- Product
- OPEN HEART TRAY - - PACK A ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF (5) DRAPE % ECONOMY 53" X 77" LIF ( 1) MAYO STAND COVER REINFORCED LIF (7) DRAPE UTILITY WITH TAPE L/F (8) HUCK CLOTH TOWELS WHITE L/F (20) HUCK CLOTH TOWELS BLUE LIF (1) MAYO TRAY LARGE LI
- Manufacturer
- Customed, Inc
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 (2)
- Product code 900-1393
- 6 lots: 112041420 113078354 113109651 140211586 140312499 140613718
Distribution
Part of a larger recall action
This product is one of 233 recalled by Customed, Inc 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 233 products in this recall →Related recalls
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