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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-2435-2014 - KNEE ARTHROSCOPY PACK
CONTENTS:
(1) TOWEL ABSORBENT 15" X 20" L/F (10) GAUZE SPONGE 4" X 4" 16PLY
(1) SAFETY IV INTROCAN 18 X 1Y. ST. LIF (1) NEEDLE HYPODERMIC 18G X 1Y:z
(1) U-DRAPE 60...
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1
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08/29/2014
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FEI # 2648727 Customed, Inc
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Z-2458-2014 - KNEE ARTHROSCOPY PACK 4
CUSTOMED
CONTENTS:
(1) COVER TABLE REINFORCED 50" X 90"
(1) GOWN SURG REINFORCED LARGE TOWEL WRAP AAMI LEVEL Ill
(1) PRE PAD CUFF
(1) COVER MAYO STAND REINFORCED
...
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1
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08/29/2014
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FEI # 2648727 Customed, Inc
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Z-2499-2014 - 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 ...
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1
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08/29/2014
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FEI # 2648727 Customed, Inc
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Z-2324-2014 - LABOR & DELIVERY PAC -
1) NEEDLE HYPODERMIC 18G X 1% ST.
(2) DRAPE UNDERBUTTOCK WITH POUCH
(4) TOWELS ABSORBENT 15" X 20"
( 1) FEEDING TUBE 8FR, 15" LONG
( 1) BEANNIES BABY
( 1) SYRINGE 20cc ...
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1
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08/29/2014
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FEI # 2648727 Customed, Inc
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Z-2379-2014 - LAMINECTOMY PACK -
( I) RING BASIN LIF
(2) TABLE COVER REINFORCED 50" X 90" LIF
( I) SKIN MARKER INK W/8 LABEL
( I) CAUTERY TIP POLISHER LIF
( I) TUBE SUCTION CONNECT. W' X 12' LIF
(6) DRAPE ...
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1
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08/29/2014
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FEI # 2648727 Customed, Inc
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Z-2377-2014 - LAP AROSCOPY PACK -
(10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF
(1) MAYO STAND COVER REINFORCED L/F
(4) ADHESIVE BANDAGE%" X 3" ST. LIF
(1) TABLE COVER REINFORCED 50" X 90" LIF
(2) GOWN IMPERVIOUS ...
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1
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08/29/2014
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FEI # 2648727 Customed, Inc
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Z-2483-2014 - LAP Abdom w/pouch Customed code 900-2619, contains:
(1) DRAPE LAP. ABDOM W/POUCH 102" X 122" X 78"
(1) WRAPPER 30" X 30"
Product Usage:
EO sterilized surgical convenient packs packaged into poly...
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1
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08/29/2014
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FEI # 2648727 Customed, Inc
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Z-2444-2014 - LAPAROSCOPIA COLORECTAL PACK
CONTENTS:
(1) SOLUTION SURGICAL DURAPREP 26ml
(4) DRAPE UTILITY WITH TAPE
(1) TOWELS ABSORBENT 15" X 20"
(2) LEGGINS W/7" CUFF 30" X 42"
(1) BLADE SURGICA...
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1
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08/29/2014
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FEI # 2648727 Customed, Inc
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Z-2466-2014 - LAPAROSCOPY ABO PACK (1) (2)
CUSTOMED
CONTENTS:
(1) GOWN SURG. REINFORCED X-LARGE TOWEL I WRAP (2) TOWELS ABSORBENT 15" X 20"
(2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED
(1) MAYO STAND COVE...
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1
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08/29/2014
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FEI # 2648727 Customed, Inc
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Z-2404-2014 - LAPAROSCOPY CHOLE PACK -
(1) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF
(2) SHEET DRAPE 42" X 57" SMS
(1) TUBE SUCTION CONNECT. %" X12' LIF
(1) SURGICAL BLADE #10 STAINLESS STEEL
(1) TABLE COV...
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1
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08/29/2014
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FEI # 2648727 Customed, Inc
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