FDA-Device2014-09-10Class I
PREMIUM UROLOGY PACK - CUSTOMED- (1) LITHOTOMY DRAPE W/POUCH ANESTH. (2) ABSORBENT TOWELS UF (1) MAYO STAND COVER REINFORCED UF (1) URINARY DRAINAGE BAG 2000ml ANTI-REFLUX UF (1) GOWN SURG. REINFORCED LARGE T/WRAP (1) UTILITY BOWL 32 OZ. (1) TUBE SUCTION CONNEC. W' X 12' UF (1) TABLE COVER REINFORCED 50" X 90" UF (1) TUR Y SET 81 "2.1M REGULAR CLAM ST. (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL EO sterilized surgical convenient packs packaged
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; 258 units (multiple units per lot)
Manufactured in
Calle Igualdad Final #7, Fajardo, PR, United States
Products
PREMIUM UROLOGY PACK - CUSTOMED- (1) LITHOTOMY DRAPE W/POUCH ANESTH. (2) ABSORBENT TOWELS UF (1) MAYO STAND COVER REINFORCED UF (1) URINARY DRAINAGE BAG 2000ml ANTI-REFLUX UF (1) GOWN SURG. REINFORCED LARGE T/WRAP (1) UTILITY BOWL 32 OZ. (1) TUBE SUCTION CONNEC. W' X 12' UF (1) TABLE COVER REINFORCED 50" X 90" UF (1) TUR Y SET 81 "2.1M REGULAR CLAM ST. (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL 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-2383-2014Don't want to check this manually?
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