Customed Recalls Colorectal Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 626 units of Laparoscopia Colorectal 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 (loss of sterility/contamination) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Customed, Inc. is recalling 626 units of the Laparoscopia Colorectal Pack (Product Code 900-2259) across 17 lots. The recall is due to a determination that packaging integrity may be compromised on different catalog numbers. The affected product consists of EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
The compromised packaging integrity could result in an injury to the patient due to product contamination or loss of sterility condition. The recall covers 17 specific lots, including lot numbers 112083065, 112114604, 113015509, 113025814, 113036344, 113046904, 113056793, 113057467, 113067917, 113078474, 113088795, 113099487, 113109794, 131110245, 131210648, 131211017, and 140211501.
The affected products were distributed worldwide, including nationwide in the United States (specifically 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 stop using the affected products and contact Customed, Inc. for further instructions.
The recalled product
- Product
- LAPAROSCOPIA COLORECTAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml (4) DRAPE UTILITY WITH TAPE (1) TOWELS ABSORBENT 15" X 20" (2) LEGGINS W/7" CUFF 30" X 42" (1) BLADE SURGICAL #15 STAINLESS STEEL (1) BLADE SURGICAL #11 STAINLESS STEEL (1) GOWN IMPER
- 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 900-2259
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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