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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-2512-2014 - TLIF PACK
SURGICAL CENTER, CODE 900-2918.
CONTENTS:
(2) SOLUTION SURGICAL DURAPREP 26ML UF
(6) Pr. GLOVE SURG. DERMA PRENE # 8 PF UF
(4) GOWN SOFT SMS STD XL SET IN SLEEVE UF
(4) T...
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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-2486-2014 - Shoulder pack (I) (2), code 900-2515
(1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL Ill
(1) TOWEL ABSORBENT 15" X 20"
(1) GOWN XXL SMS IMPERVIOUS REINFORCED
(1) MAYO STAND COVER REINFORCED
(2) STR...
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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-2481-2014 - Shoulder Pack, Code 900-2616, contains:
(2) TUBE SUCTION CONNECT Y."X12' UF
(1) SYRINGE 20CC W/0 NDL UL UF
(2) DRAPE VIDEO CAMERA UF
(1) COVER MAYO STAND REINF. UF
(5) SPONGE LAP. PRE-WASH XRD ...
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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-2500-2014 - Shoulder Arthroscopy Pack, code 900-2719, contains:
(1 0) GAUZE SPONGES 4 X 4 12PL Y
(1) COBAN WRAP TAN 4 X 5yds
(3) PAD ABDOMINAL 8 X 7.5
(1) DRESSING 1 X 8 XEROFORM PETROLAT
(1 0) GAUZE SPONGES...
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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-2441-2014 - SURGICAL PACK
CONTENTS:
(1) SUTURE BAG FLORAL
(1) WRAPPER 30" X 30"
(2) UTILITY BOWL 16oz
(1) TRAY ORGANIZER FULL DEEP
(1) SPECIMEN CONTAINER 4oz W/LID & LABEL (1) YANKAUER SUCTION TU...
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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-2362-2014 - STRABISMUS & PLASTIC PACK - (1) TABLE COVER REINFORCED 44" X 78" UF
(2) GOWN STANDARD LARGE SMS
(3) TOWELS ABSORBENT 15" X 20" UF
(1) MAYO STAND COVER REINFORCED UF
(1) DRAPE SHEET 41" X 58" SMS
...
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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-2426-2014 - SHOULDER PACK- CUSTOMED-
(1) TABLE COVER REINFORCED 50" x 90" LIF
(2) MAYO STAND COVER REINFORCED L/F
(1) U-DRAPE 60" X 70" WITH TAPE SPLIT
(4) TOWELS ABSORBENT 15" X 20" LIF
(4) DRAPE UTILITY ...
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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-2505-2014 - SHOULDER PACK
CODE 900-2766
CONTENTS:
(1) STAPLE SKIN 35 WIDE LIF
(1) *GOBAN SELF-ADH 4" X 5YD WRAP TAN LATEX (2) U-DRAPE 60" X 70" WITAPE SPLIT 6" X 21"
(1) TABLE COVER 44" X 90"
(4)...
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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-2439-2014 - SHOULDER ARTHROSCOPY PACK
CONTENTS:
(1) SUTURE BAG FLORAL
(1) UTILITY BOWL 32oz.
(2) DRAPE SHEET 70" X 100"
(1) GOWN SURG REINFORCED XLGE T/WRAP (1) NEEDLE SPINAL ANESTH. 18G X 3ST.
(1) ...
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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-2393-2014 - REYITO UROLOGY PACK -
(2) GOWN IMP. REINFORCED X-LARGE SMS
(2) TOWELS ABSORBENT UF
( I) URINARY DRAIN. BAG 2000ML ANTI-REFLUX UF
( I) SYRINGE 30cc W/0 NDL. LUER LOCK UF
( I) BAG SUTURE
(I) T...
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1
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08/29/2014
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FEI # 2648727 Customed, Inc
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