Customed, Inc Recall: FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PV
Customed, Inc Recall: FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PV is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Customed, Inc; Product: FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PVP TRIPLE SWABSTICK IODOPHOR (2) GLOVE MED FREETOUCH VYN
| Recalling firm | Customed, Inc |
|---|---|
| Product | 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. |
| Reason for recall | 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. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| Distribution | Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico. |
| Recall initiated | 20140520 |
| Recall number | Z-2373-2014 |
| Category | device |
| State | PR |
| Country | United States |
$29/mo
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