Customed Recalls Foley Catheter Kits Due to Packaging Integrity Concerns
Customed, Inc. is recalling 13 lots of Foley Catheter 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 (injury due to contamination or loss of sterility) from a medical device, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Customed, Inc. is recalling 13 lots of Foley Catheter Kits (Product Code 900-1139) due to a potential compromise in packaging integrity. The affected kits contain various medical supplies, including a Foley catheter, gloves, swabsticks, and a urinary drainage bag, packaged in a polyester/polyethylene breather bag with Tyvek double vents.
The recall was initiated because the company determined that the packaging integrity may be compromised on multiple catalog numbers. This defect could result in product contamination or a loss of sterility, which poses a risk of injury to patients using the devices.
The affected products were distributed worldwide, including nationwide in the United States (specifically noting Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. A total of 12,820 units are involved in this recall. Users should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS: (1) WRAPPER 24" X 24" (1) LABEL ID PATIENT (1) TRAY ORGANIZER (1) PVP TRIPLE SWABSTICK IODOPHOR (2) GLOVE MED FREETOUCH VYNIL P/F (1) JELLY LUBRICATING 5 GRAM (1) TOWEL 3PL Y POLY 17" X 18" (2) SWABSTICK DRY COTTON (1)
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Catheters
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 900-1139
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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