FDA-Device2014-09-10Class I
LAPAROTOMY PACK - (I) SURGICAL BLADE #10 S/STEEL ( I) UTILITY BOWL 32oz (I) UTILITY BOWL 16oz (2) NEEDLE & BLADE COUNTER IOC MAG/CLEAR ( I) DRAPE T LAPAROTOMY STD SMS (2) TOWELS ABSORBENT 15" x 20" (2) GOWN IMP. REINFORCED LARGE SMS (4) DRAPE UTILITY WITH TAPE ( I) TABLE COVER REINFORCED 50" X 90" ( I) MAYO STAND COVER REINFORCED ( I) ELECTRODE DUAL DEPRES./GROUNDPAD ( I ) CAUTERY PENCIL ROCKER SWITCH (2) DRAPE SHEET 42" X 55" SMS EO sterilized surgical convenient packs pa
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
20 lots; 3576 units (multiple units per lot)
Manufactured in
Calle Igualdad Final #7, Fajardo, PR, United States
Products
LAPAROTOMY PACK - (I) SURGICAL BLADE #10 S/STEEL ( I) UTILITY BOWL 32oz (I) UTILITY BOWL 16oz (2) NEEDLE & BLADE COUNTER IOC MAG/CLEAR ( I) DRAPE T LAPAROTOMY STD SMS (2) TOWELS ABSORBENT 15" x 20" (2) GOWN IMP. REINFORCED LARGE SMS (4) DRAPE UTILITY WITH TAPE ( I) TABLE COVER REINFORCED 50" X 90" ( I) MAYO STAND COVER REINFORCED ( I) ELECTRODE DUAL DEPRES./GROUNDPAD ( I ) CAUTERY PENCIL ROCKER SWITCH (2) DRAPE SHEET 42" X 55" SMS 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-2315-2014Don't want to check this manually?
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