Customed Recalls O.B. Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling O.B. 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 identifies the agency classification as Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Customed, Inc. is recalling O.B. Packs (Product Code 900-2002) due to a determination that packaging integrity may be compromised across multiple catalog numbers and lots. The recall involves 23 lots and 1,396 units. The product consists of EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
The recall is being conducted because the compromised packaging integrity could result in an injury to the patient due to product contamination or loss of sterility condition. The agency has classified this as a Class I recall.
The affected products were distributed worldwide, including nationwide in the United States (specifically noting Florida, Puerto Rico, and USVI) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Consumers and healthcare facilities should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- O.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" ( I) DRAPE ABDOMINAL WITH TAPE LIF ( I) VAGINAL PACKING SPONGEXRD ( I) BOWL WITH LID PLASTIC 80oz ( I) RECEIVING BLANKET 100% COTTON (I) BABY BLANKET POLY AB
- 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 900-2002
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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