Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" Recalled by Customed, Inc Due to Customed has determined that there is the possibility...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Customed, Inc directly.
Affected Products
FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PVP TRIPLE SWABSTICK IODOPHOR (2) GLOVE MED FREETOUCH VYNIL P/F (1) JELLY LUBRICATING 5 GRAM (1) TOWEL 3PLY POLY 17" X 18" (2) SWABSTICK DRY COTTON (1) DRAPE 4" FENESTRATED 18" X 26" (1) CATHETER 16FR. FOLEY, 2 WAY,5cc, Silicone Coated (1) SYRINGE 10cc WATERPREFIL UF (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX UF (1) LABEL ID PATIENT (1) TRAY ORGANIZER (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Quantity: 27 lots; 67410 units (multiple units per lot)
Why Was This Recalled?
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Customed, Inc
Customed, Inc has 682 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report