FDA-Device2014-09-10Class I
CYSTO TUR PACK BASIC CODE 900-2899. CONTENTS: (2) LEGGINGS W/7'' CUFF 30" X 42" (1) COVER TABLE REINFORCED 44" X 78" (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XLGE SMS IMPERV. REINFORCED AAMI LEVEL Ill (1) TUR CYSTO IRRIGATION SET 79" SINGLE (1) TIME OUT BEACON NON WOVEN ST (1) BAG SUTURE FLORAL (1) UTILITY BOWL 32oz (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) TURP CYSTO DRAPE WITH POUCH (1) GOWN IMPER EXTRA REINF LGE AAMI LEVEL Ill TOWEL & WRAP Product Usage: EO sterilized surg
Customed, Inc
Hazard
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.
Sold states
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.
Affected count
2 lots,128 units (multiple units per lot)
Manufactured in
Calle Igualdad Final #7, Fajardo, PR, United States
Products
CYSTO TUR PACK BASIC CODE 900-2899. CONTENTS: (2) LEGGINGS W/7'' CUFF 30" X 42" (1) COVER TABLE REINFORCED 44" X 78" (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XLGE SMS IMPERV. REINFORCED AAMI LEVEL Ill (1) TUR CYSTO IRRIGATION SET 79" SINGLE (1) TIME OUT BEACON NON WOVEN ST (1) BAG SUTURE FLORAL (1) UTILITY BOWL 32oz (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) TURP CYSTO DRAPE WITH POUCH (1) GOWN IMPER EXTRA REINF LGE AAMI LEVEL Ill TOWEL & WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2508-2014Don't want to check this manually?
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