FDA-Device2014-09-10Class I
LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED L/F (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL BLADE #11 CARBON STEEL (1) TUR Y SET, 2LEAD L/F (4) DRAPE UTILITY WITH TAPE LIF (1) TROCAR ENDO. XCEL DILATING TIP 5mm (K5LT) (1) ULTRA VERES NEEDLE 120mm (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (1) DRAPE LAP. ABDOM. WITH POUCH 102" X 122" X 78" (2) DRAPE SHEET 41" X 58" SMS (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (10)
Customed, Inc
Hazard
Customed has determined that there is the possibility that packaging integrity may be compromised on differ 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
11 lots; 681 units (multiple units per lots)
Manufactured in
Calle Igualdad Final #7, Fajardo, PR, United States
Products
LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED L/F (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL BLADE #11 CARBON STEEL (1) TUR Y SET, 2LEAD L/F (4) DRAPE UTILITY WITH TAPE LIF (1) TROCAR ENDO. XCEL DILATING TIP 5mm (K5LT) (1) ULTRA VERES NEEDLE 120mm (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (1) DRAPE LAP. ABDOM. WITH POUCH 102" X 122" X 78" (2) DRAPE SHEET 41" X 58" SMS (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD L/F (5) LAP SPONGE PREWASH XRD LIF (1 ) DRAPE LASER CAMERA W/EL. 6" X 96" LIF (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) TROCAR ENDOPATH XCEL DILATING TIP 11mm (K1 1LT) (1) TUBING INSUFLATION SET W/0 RING ADAPTOR LIF (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) TABLE COVER REINFORCED 50" X 90" LIF 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-2429-2014Don't want to check this manually?
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