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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-2332-2014 - PERY GYN PACK -
(1) TABLE COVER REINFORCED 44" X 78"
(1) DRAPE UTILITY
(2) TOWELS ABSORBENT 15" X 20"
(1) GOWN XL SMS IMPERV. REINF. AAMI LEVEL Ill
(1) DRAPE UNDERBUTIOCK W/POUCH 44" X 35"
...
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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-2333-2014 - LAPAROSCOPY CHOLECYSTECTOMY PACK -
(1) SHEET LAPAROS/ABDOMINAL UF
(1) MAYO STAND COVER REINFORCED UF
(1) BLADE SURGICAL #11 STAINLESS STEEL
(1) DRAPE SHEET 41 " X 58" SMS UF
(10) GAUZE SPONGE...
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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-2334-2014 - LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK - -
(1) DRAPE LAPAROS/ABDOMINAL UF
(1) GOWN IMPER. EXTRA REINFORCED LGE TIVVRAP
(1) BLADE SURGICAL #11 STAINLESS STEEL
(1) TIME OUT BEACON NON WOVE...
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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-2335-2014 - LAPAROSCOPY GYN PACK - -
(1) BLADE SURGICAL #11 STAINLESS STEEL
(4) DRAPE UTILITY WITH TAPE LIF
(2) ABSORBENT TOWEL 15" X 20" LIF
(1) GOWN IMPERVIOUS REINFORCED LARGE SMS
(1) TOWEL CLOTH HUCK B...
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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-2336-2014 - ANGIOGRAPHY PACK -
( 1) FEMORAL ANGlO. DRAPE WITH POUCH
(2) SYRINGE 10cc W/0 NEEDLE LUER LOCK LIF
(2) NEEDLE HYPODERMIC 21G X 1%
( 1) TABLE COVER REINFORCED 44" X 78" LIF
(30) GAUZE SPONGES 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-2337-2014 - LAPAROSCOPY GYN PACK -
(1) TABLE COVER REINFORCED 44" X 78"
(1) LAPAROSCOPY SHEET "T" SMS
(3) TOWELS ABSORBENT 15" X 20"
(1) SURGICAL BLADE#11 STAINLESS STEEL
(1) MAYO STAND COVER 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-2338-2014 - ARTHROSCOPY PACK -
(1) MAYO STAND COVER REINFORCED LIF
(1 0) GAUZE SPONGES 4" X 4" 16PL Y
(1) TUBE SUCTION CONNECTING X" X 12' LIF
(1) IMP. STOCKINETTE
(1) SURGICAL BLADE #11 STAINLESS STEEL
(...
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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-2339-2014 - O.R. TOWELS- CUSTOMED-
(6) TOWELS CLOTH HUCK BLUE
( I) WRAPPER 20" X 20
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
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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-2340-2014 - FANFOLD DRAPE - CUSTOMED
(1) DRAPE SHEET 42" X 57" SMS
(1) WRAPPER 24" X 24"
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
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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-2341-2014 - PERY GYN PACK-
(1) DRAPE UTILITY WITH TAPE UF
(1) UNDERBUTTOCK DRAPE WITH POUCH
(2) ABSORBENT TOWELS 15" x 20" UF
(2) LEGGINS W/7'' CUFF 30" X 42"
(1) TABLE COVER REINFORCED 50" X 90" UF
(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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