Customed Recalls HIP PACK Surgical Kits Due to Packaging Integrity Concerns
Customed, Inc. is recalling HIP PACK surgical kits 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) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Customed, Inc. is recalling HIP PACK surgical kits, which contain absorbent towels, gowns, drapes, and other surgical supplies. The recall involves 4 lots totaling 110 units. The specific product code is 900-2184, and the affected lot numbers are 111041038, 111071378, 111082085, and 112062292.
The recall was initiated because Customed determined that the packaging integrity of these kits may be compromised. This defect could result in product contamination or a loss of the sterile condition, which poses a risk of injury to patients. The products were EO sterilized and packaged in polyester/polyethylene breather bags with Tyvek double vents.
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. Users should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- HIP PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) GOWN XL SMS IMPERV. REINFORCED (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG (1) DRAPE UTILITY WITH TAPE (1) STOCKINETTE IMPERV. 14" X 48" (1) U-DRAPE 54 X 72 WITH TAPE SPLIT HIP DRAPE 89" X 128" WITH POU
- Manufacturer
- Customed, Inc
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 900-2184
- 4 lots 111041038 111071378 111082085 112062292
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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