Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling specific lots of EO-sterilized surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Customed, Inc. has initiated a recall for specific lots of EO-sterilized surgical convenient packs, including items such as gowns, towels, and drapes. The recall involves two lots, totaling 354 units, with catalog code 900-2515. The affected products were distributed worldwide, including in the United States (nationwide, Florida, Puerto Rico, USVI) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
The recall was issued because Customed determined that there is a possibility that packaging integrity may be compromised on these products. This defect could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients. The agency has classified this recall as Class I.
Healthcare facilities and consumers who have these specific lots should stop using the products immediately. Users should check their inventory for the affected lot numbers (112104283 and 113078531) and contact Customed, Inc. for instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- Shoulder pack (I) (2), code 900-2515 (1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL Ill (1) TOWEL ABSORBENT 15" X 20" (1) GOWN XXL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (2) STRIPS TAPE 24" X 4" (1) SUTURE BAG FLORAL (1) SHEET SPLIT W/ADHESIVE 1 08" X 77"
- 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 (2)
- 900-2515
- 2 lots: 112104283 113078531
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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