Customed Recalls EO Sterilized Surgical Drape Sheets Due to Packaging Integrity
Customed, Inc. is recalling EO sterilized surgical drape sheets 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 (loss of sterility/contamination) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Customed, Inc. is recalling EO sterilized surgical drape sheets, Product Code 2942, due to a potential compromise in packaging integrity. The affected product consists of a drape and wrapper packaged in a polyester/polyethylene breather bag with Tyvek double vents.
The recall involves three lots totaling 5,460 units. The company determined that the possibility of compromised packaging could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients.
The affected products were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. The specific lot codes are 113067718, 113078516, and 113088808.
The recalled product
- Product
- Drape Sheet, Product Code 2942, contains (1) DRAPE % ECONOMY 53 X 77L/F (1) WRAPPER 24 X 24 L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Drapes
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)
- Code 900-2942: 113067718 113078516 113088808
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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