Customed Recalls PERY GYN PACK Surgical Drapes Due to Packaging Integrity Concerns
Customed, Inc. is recalling PERY GYN PACK 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 is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The source text identifies a risk of injury due to contamination or loss of sterility, but does not report any actual injuries or illnesses.
Plain-English summary
Customed, Inc. is recalling 53 lots of PERY GYN PACK surgical convenient packs. The product consists of EO sterilized surgical drapes, towels, and legging components packaged in polyester/polyethylene breather bags with Tyvek double vents. The recall involves 1,800 units distributed worldwide, including the United States (nationwide, Florida, Puerto Rico, USVI), Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
The recall was initiated because Customed determined there is a possibility that packaging integrity may be compromised on different catalog numbers. This defect could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients.
Healthcare facilities and distributors should stop using the affected lots immediately. The specific lot numbers are listed in the agency's recall record Z-2406-2014. Users should contact Customed, Inc. for instructions on returning or disposing of the recalled products.
The recalled product
- Product
- PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE (1) DRAPE UNDERBUTIOCK WITH POUCH (1) TOWELS ABSORBENT 15" x 20" UF (2) LEGGINS W/7'' CUFF 30" X 42" (1 ) TABLE COVER REINFORCED 50" X 90" UF (1) DRAPE ABDOMINAL WITH TAPE UF EO sterilized surgical convenient packs packaged int
- 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)
- Product code 900-1716
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.
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