FDA-Device2014-09-10Class I
SHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL (1) UTILITY BOWL 32oz. (2) DRAPE SHEET 70" X 100" (1) GOWN SURG REINFORCED XLGE T/WRAP (1) NEEDLE SPINAL ANESTH. 18G X 3ST. (1) STOCKINETTE 6 X 48" (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (1) SCALPEL WEIGHTED SAFETY# 11 (1) BULB SYRINGE 60cc (1) DRAPE BEACH CHAIR SHOULDER ARTHROSCOPY (10) LAP SPONGE PREWASH 18" X 18" XRD (2) U-DRAPE 60" X 70" WITH TAPE SPLIT (2) DRAPE SHEET 41" X 58" SMS (1) STOCKINET
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
28 lots/1707 units (multiple units per lot)
Manufactured in
Calle Igualdad Final #7, Fajardo, PR, United States
Products
SHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL (1) UTILITY BOWL 32oz. (2) DRAPE SHEET 70" X 100" (1) GOWN SURG REINFORCED XLGE T/WRAP (1) NEEDLE SPINAL ANESTH. 18G X 3ST. (1) STOCKINETTE 6 X 48" (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (1) SCALPEL WEIGHTED SAFETY# 11 (1) BULB SYRINGE 60cc (1) DRAPE BEACH CHAIR SHOULDER ARTHROSCOPY (10) LAP SPONGE PREWASH 18" X 18" XRD (2) U-DRAPE 60" X 70" WITH TAPE SPLIT (2) DRAPE SHEET 41" X 58" SMS (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) TABLE COVER REINFORCED 50" X 90" (1) COBAN WRAP TAN 4" X 5yds (1) TIME OUT BEACON NON WOVEN (2) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL IV (2) MAYO STAND COVER REINFORCED (1) SKIN MARKER INK WITH 8 LABEL (1) TUBE CONNECTING SUCTION X" X 12' (1) MAYO TRAY SMALL ( 1) CAMERA COVER W/ELAST. 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-2439-2014Don't want to check this manually?
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