Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 46 lots of EO sterilized surgical convenient packs because packaging integrity may be compromised, potentially leading to 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 packs) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical risk of contamination or loss of sterility.
Plain-English summary
Customed, Inc. is recalling 46 lots of EO sterilized surgical convenient packs, specifically the Strabismus & Plastic Pack. The affected products include table covers, gowns, towels, mayo stand covers, drape sheets, and utility drapes packaged in polyester/polyethylene breather bags with Tyvek double vents. The recall involves 1,240 units manufactured across the 46 lots.
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 an injury to the patient due to product contamination or loss of sterility condition. The source text does not report any specific illnesses or injuries associated with this recall.
The affected products were distributed worldwide, including nationwide in the United States (specifically mentioning 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 check their inventory for the specific lot numbers listed in the recall notice and stop using the affected products if found.
The recalled product
- Product
- STRABISMUS & PLASTIC PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) GOWN STANDARD LARGE SMS (3) TOWELS ABSORBENT 15" X 20" UF (1) MAYO STAND COVER REINFORCED UF (1) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILITY WITH TAPE L/F EO sterilized surgical convenient packs packa
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
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 900-946
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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