FDA-Device2014-09-10Class I
Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD XLGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO STAND COVER REINFORCED (2) TABLE COVER REINFORCED 50 X 90 (1) SUTURE BAG FLORAL (1) TUBE SUCTION CONNECT Y (6) TOWEL CLOTH HUCK BLUE (4) PAD ABDOMINAL 8 X 7.5 (2) LITE GLOVES (1) CAUTERY TIP POLISHER LIF (1) BLADE SURGICAL CARBON STEEL 15 (1) YANKAUER SUCTION TUBE W/0 VENT (1 0) LAP SPONGE PREWASH 18 X 18 XRD (1) CAUTERY PENCI
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/ 54 units, multiple units per lot
Manufactured in
Calle Igualdad Final #7, Fajardo, PR, United States
Products
Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD XLGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO STAND COVER REINFORCED (2) TABLE COVER REINFORCED 50 X 90 (1) SUTURE BAG FLORAL (1) TUBE SUCTION CONNECT Y (6) TOWEL CLOTH HUCK BLUE (4) PAD ABDOMINAL 8 X 7.5 (2) LITE GLOVES (1) CAUTERY TIP POLISHER LIF (1) BLADE SURGICAL CARBON STEEL 15 (1) YANKAUER SUCTION TUBE W/0 VENT (1 0) LAP SPONGE PREWASH 18 X 18 XRD (1) CAUTERY PENCIL ROCKER SWITCH W/HOLSTER (1) UNDERPAD 23 X 36 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-2492-2014Don't want to check this manually?
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