Device Recall Customed

2

No

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.

Breast Augmentation Pack, Imagenes Cosmetic, code 900-2682: || (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE || ( 1) CAUTERY PENCIL PUSH BOTTOM || ( 1) TUBE SUCTION CONNECT || ( 1) MAYO STAND COVER REINFORCED || ( 1) SKIN MARKER INK W LABEL || (2) TABLE COVER REINFORCED 50 X 90 || ( 1) RULER 6 CLEAR || (6) TOWEL CLOTH HUCK (BLUE) || (10) LAP SPONGE PREWASH 18 X 18 XRD || ( 1) CAUTERY TIP POLISHER || ( 1) YANKAUER SUCTION TUBE W/O VENT || ( 1) DRAPE BREAST/CHEST SMS || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

2

No

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.

Tummy Tuck Pack, code 900-2684, contains: || (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE || ( 1) CAUTERY PENCIL PUSH BOTTOM || ( 1) TUBE SUCTION CONNECT || ( 1) MAYO STAND COVER REINFORCED || ( 1) SKIN MARKER INK W LABEL || (2) TABLE COVER REINFORCED 50 X 90 || ( 1) RULER 6 || (6) TOWEL CLOTH HUCK (BLUE) || (10) LAP SPONGE PREWASH 18 X 18 XRD || ( 1) CAUTERY TIP POLISHER || ( 1) DRAPE BREAST/CHEST SMS || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

2

No

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.

Bandeja para Debridacion, code 900-2702, contains: || (1) FORCEP ADSON TISS || (20) GAUZE SPONGES 4 X 4 12PL Y || (1) SCISSORS IRIS STRAIGHT 4.5 W/PROTECTOR TIP || (1) TOWEL 3 PLY POLY 13 X 18 || (1) DRAPE 18 X 26 WHITE/WHITE POLYPROPYLENE || (1) CHLORASCRUB SWABSTICK 1.6 ML || (1) TRAY KUTIER || (1) SCALPEL W/HANDLE 20 || (1 i WRAPPER 24 X 24 || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

1

No

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.

Endovascular Pack, code 900-2715, contains: || ( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH POUCH LIF || (2) TOWELS ABSORBENT 15 X 20 LIF || ( I) CONTAINER SPECIMEN 4oz W/LID & LABEL Llf || (2) BAG BAND FLUOROSCOPE 36 X 30 LIF || ( I) NEEDLE HYPODERMIC 21G X I Y, LIF || (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI III LIF || (2) SOLUTION SURGICAL DURAPREP 6ML LIF || ( I) BAG BAND RUB BAND & TAPE 42 X 38 LIF || (4) TOWELS CLOTH HUCK BLUE LIF || (I) Pr. GLOVE SYNTEGRA CR 6.5 POWDER FREE Llf || (2) Pr. GLOVE SYNTEGRA CR 8 POWDER FREE LIF || ( I) NEEDLE HYPODERMIC 25G X 5/8 LIF || ( I) SYRINGE 30CC WITHOUT NEEDLE LUER LOCK LIF || (I) COYER TABLE 44 X 90 LIF || ( I) SCALPEL WITH HANDLE || (25) GAUZE SPONGES 4 X 4 12PLY LIF || (2) CLAMP TOWEL || (2) SYRINGE I OCC WITHOUT NEEDLE LUER LOCK LIF || ( I) NEEDLE HYPODERMIC 18G X I Y, LIF || ( I) SHARP STOP NEEDLE HOLDER LIF || ( I) TRAY ORGANIZER FULL DEEP || ( I) NEEDLE 18G X 23 || (I) BOWL UTILITY BLUE 16oz LIF || ( I) WRAPPER 24X 24 LIF || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

1

No

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.

Knee Arthroscopy Pack, code 900-2718, contains: || (1 0) GAUZE SPONGES 4 X 4 12PL Y || (2) PADDING CAST SOFT ROLL 6 X 4yds. || (1) GOBAN SELF-ADHERENT WRAP 6 X 5yds || (3) PAD ABDOMINAL 8 X 7.5 || (1) DRESSING 1 X 8 XEROFORM PETROLAT || (10) GAUZE SPONGES 4 X 4 16PLY XRD || (3) NEEDLE HYPODERMIC 18G X 1 || (1) NEEDLE SPINAL ANESTH 18G X 3 || (1) NEEDLE HYPODERMIC 22G X 1 || (1) SYRINGE 30cc W/0 NEEDLE LUER LOCK || (1) SCALPEL W/HANDLE 11 || (1) SKIN MARKER W/RULER || (9) LABELS FOR SKIN MARKERS || (1) RULER || (3) Pr. GLOVESURG 8 DERMA PRENE POWDER FREE || (1) BANDAGE ELASTIC KNIT STD 10yds || (1) BANDAGE ESMARK 6 X 9yds || (8) TOWELS CLOTH HUCK BLUE || (1) U - DRAPE 60 X 70 WIT APE SPLIT 6 X 21 || (1) SHEET 60 X 77 DRAPE REINFORCED || (2) SOLUTION SURGICAL DURAPREP 26ML || (3) TUBE SUCTION CONNECT || (1) BOWL UTILITY 16oz. || (1) COVER TABLE REINFORCED 50 X 90 || (2) GOWN SURGICAL REINFORCED X-LARGE || (1) GOWN SURGICAL REINFORCED X-LARGE T/WRAP || (2) TOWELS ABSORBENT 15X 20 || (1) STOCKINETTE IMPERV 12 X 48 || (2) BAG PLASTIC 6 X 12 || (1) KNEE ARTHROSCOPY DRAPE || (1) FILTER STRAW 5 MICRO || (2) LITE GLOVE || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.