Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 3,576 units of EO sterilized laparotomy packs because packaging integrity may be compromised, risking loss of sterility and patient injury.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must never go below 4.
Plain-English summary
Customed, Inc. is recalling 3,576 units of EO sterilized laparotomy packs (Product code 900-281) across 20 lots. The recall is due to the possibility that packaging integrity may be compromised on different catalog numbers. The affected products are surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
The compromised packaging could result in an injury to the patient due to product contamination or loss of sterility condition. The agency classifies this recall as Class I.
The affected lots 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. Users should stop using the affected products and contact the manufacturer for instructions.
The recalled product
- Product
- LAPAROTOMY PACK - (I) SURGICAL BLADE #10 S/STEEL ( I) UTILITY BOWL 32oz (I) UTILITY BOWL 16oz (2) NEEDLE & BLADE COUNTER IOC MAG/CLEAR ( I) DRAPE T LAPAROTOMY STD SMS (2) TOWELS ABSORBENT 15" x 20" (2) GOWN IMP. REINFORCED LARGE SMS (4) DRAPE UTILITY WITH TAPE ( I)
- 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 900-281
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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