Customed Recalls OB Packs Due to Potential Packaging Integrity Compromise
Customed, Inc. is recalling OB Packs 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 product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential contamination or loss of sterility.
Plain-English summary
Customed, Inc. is recalling OB Packs (Product Code 900-1238, Lot 109071538) due to a potential compromise in packaging integrity. The recall involves 30 units from a single lot. The affected products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
The recall was initiated because the compromised packaging could result in product contamination or a loss of sterility condition. This poses a risk of injury to patients using the medical supplies. The source text notes that the issue may affect different catalog numbers and multiple lots, though the specific quantity listed is 30 units for the identified lot.
The affected products were distributed worldwide, including nationwide in the United States (specifically 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 OB Packs and contact Customed, Inc. for further instructions or a replacement.
The recalled product
- Product
- OB PACK - (2) EXAM GLOVES MED. (1 0) GAUZE SPONGES 4" X 4" 12PL Y (2) LEGGINS W/ 7" CUFF (2) DRAPE SHEET SMS (1) ABDOMINAL DRAPE W/TAPE (1) PLASTIC BOWL W/Lid 70 oz. (1) EAR/ULCER SYRINGE 2oz. L/Free (1) UMBILICAL CORD CLAMP (1) BABY BEANNIES (1) PVP SCRUB 8" STICK SPO
- 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)
- Product code 900-1238
- 1 lots: 109071538
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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