CYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz LIF (1 0) GAUZE SPONGE 4" X 4" 12PL Y LIF (4) ABSORBENT TOWELS 15" X 20" LIF (1) CYSTOSCOPY 'T' DRAPE 60" X 87" X 35" SMS STD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (2) LEGGINS WITH 7" CUFF 30" X 42" LIF (1) TABLE COVER REINFORCED 44" X 78" LIF (1) UNDERBUTTOCK DRAPE WITH POUCH 44" X 35" LIF (1) SYRINGE 60ML SLUER SLIP WITHOUT NEEDLE LIF (1) TUR Y SET 81 "2.1 M REGULAR CLAM (4) GAUZE SPONGES 4" X 4" 12 PLY XRD L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Enforcement
- Recall Number
- Z-2325-2014
- 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
CYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz LIF (1 0) GAUZE SPONGE 4" X 4" 12PL Y LIF (4) ABSORBENT TOWELS 15" X 20" LIF (1) CYSTOSCOPY 'T' DRAPE 60" X 87" X 35" SMS STD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (2) LEGGINS WITH 7" CUFF 30" X 42" LIF (1) TABLE COVER REINFORCED 44" X 78" LIF (1) UNDERBUTTOCK DRAPE WITH POUCH 44" X 35" LIF (1) SYRINGE 60ML SLUER SLIP WITHOUT NEEDLE LIF (1) TUR Y SET 81 "2.1 M REGULAR CLAM (4) GAUZE SPONGES 4" X 4" 12 PLY XRD L/F 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 900-430, 29 lots: 110020453 110030667 110051146 111030671 111040897 111061672 111071814 111082217 111092389 111102877 111113116 111123253 112010174 112030874 112041411 112072872 112083431 113015513 113015697 113036365 113047211 113057626 113078328 113088864 113109841 131110304 140111229 140312164 140412467
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.
29 lots; 870 units (multiple units per lot)