Customed recalls surgical drapes due to potential packaging integrity issues
Customed, Inc. is recalling EO sterilized surgical drapes 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 (injury due to contamination or loss of sterility) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Customed, Inc. is recalling specific lots of the LAP Abdom w/pouch Customed code 900-2619. This product consists of EO sterilized surgical convenient packs, including a drape and a wrapper, packaged into polyester/polyethylene breather bags with Tyvek double vents. The recall involves two lots (131211019 and 140312150) totaling 288 packed units.
The recall was initiated because Customed determined there is a possibility that packaging integrity may be compromised. This defect 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.
Healthcare facilities and consumers should stop using the affected lots immediately. Users should check their inventory for the specific lot numbers 131211019 and 140312150 and contact Customed, Inc. for instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- LAP Abdom w/pouch Customed code 900-2619, contains: (1) DRAPE LAP. ABDOM W/POUCH 102" X 122" X 78" (1) WRAPPER 30" X 30" 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 (2)
- 900-2619
- 2 lots: 131211019 140312150
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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