UROLOGY PACK- (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECT Y." X12' (1) SYRINGE 30cc WITHOUT NEEDLE ULOCK (1) BASIN RING (1) TUR Y SET, 2 LEAD, ST. (1) BAG SUTURE FLORAL (1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IV (2) TOWEL CLAMP (1) DRAPE LITHOTOMY W/LEGGIN I POUCH UF 11 0" x 63" (2) SHEET DRAPE 41 " X 58" SMS (1) COVER TABLE REINF 50" X 90" (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX (3) TOWELS ABSORBENT 15" X 20" (1) GOWN IMP. SMS EXTRA REINF. XL T/WRAP LEVEL IV (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) TIME OUT BEACON NON WOVEN ST. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Enforcement
- Recall Number
- Z-2400-2014
- Event ID
- 68536
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Customed, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 10, 2014
- Initiation Date
- May 20, 2014
- Classification Date
- August 29, 2014
- Termination Date
- August 14, 2017
- Address
- Calle Igualdad Final #7, Fajardo, PR, 00738, United States
Description
UROLOGY PACK- (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECT Y." X12' (1) SYRINGE 30cc WITHOUT NEEDLE ULOCK (1) BASIN RING (1) TUR Y SET, 2 LEAD, ST. (1) BAG SUTURE FLORAL (1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IV (2) TOWEL CLAMP (1) DRAPE LITHOTOMY W/LEGGIN I POUCH UF 11 0" x 63" (2) SHEET DRAPE 41 " X 58" SMS (1) COVER TABLE REINF 50" X 90" (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX (3) TOWELS ABSORBENT 15" X 20" (1) GOWN IMP. SMS EXTRA REINF. XL T/WRAP LEVEL IV (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) TIME OUT BEACON NON WOVEN ST. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
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.
Product code 900-1521, 27 lots: 111102904 112041376 112041452 112062286 112104149 112114602 112124957 113015430 113015690 113025942 113026048 113036739 113046934 113047002 113047332 113057836 113078260 113088737 113088931 113089193 131110180 131110598 131210962 140211645 140211922 140412884 140513346
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.
27 lots; 1884 units (multiple units per lot)