FDA-Device2014-09-10Class I
LAPAROTOMY PACK- (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGES PRE-WASH 18" X 18" XRD LIF (1) LITE GLOVE LIF (1) BAG SUTURE FLORAL (1) BLADE SURGICAL #1 0 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) CAUTERY TIP POLISHER LIF (1) BAG GLASSINE (1) TABLE COVER 44" X 90" L/F (2) DRAPE SHEET 41 " X 58" SMS (1) LAPAROTOMY DRAPE "T" 102" X 78" X 121" STD SMS (4) DRAPE UTILITY WITH TAPE LIF
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
34 lots; 3603 units (multiple units per lot)
Manufactured in
Calle Igualdad Final #7, Fajardo, PR, United States
Products
LAPAROTOMY PACK- (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGES PRE-WASH 18" X 18" XRD LIF (1) LITE GLOVE LIF (1) BAG SUTURE FLORAL (1) BLADE SURGICAL #1 0 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) CAUTERY TIP POLISHER LIF (1) BAG GLASSINE (1) TABLE COVER 44" X 90" L/F (2) DRAPE SHEET 41 " X 58" SMS (1) LAPAROTOMY DRAPE "T" 102" X 78" X 121" STD SMS (4) DRAPE UTILITY WITH TAPE LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (1) TUBE SUCTION CONECT W' X 12' LIF (3) ABSORBENT TOWELS 15" X 20" LIF (1) CAUTERY PENCIL PUSH BOTTON (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL/WRAP LEVEL Ill (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF 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-2364-2014Don't want to check this manually?
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