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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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Customed, Inc
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Z-2513-2014 - Obstetrical Surgical pack,
code 900-2940, contains:
(1) BLANKET RECEIVING 100 COTTON
(3) TOWEL ABSORBENT 15 X 20 LIF
(10) GAUZE SPONGE 4 X 4 16PLY XRD LIF
(1) SYRINGE EAR/ULCER 2oz. LIF
(1) DRA...
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1
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08/29/2014
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Customed, Inc
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Z-2514-2014 - Drape Sheet, Product Code 2942, contains
(1) DRAPE % ECONOMY 53 X 77L/F
(1) WRAPPER 24 X 24 L/F
Product Usage:
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather...
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1
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08/29/2014
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Customed, Inc
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Z-2515-2014 - Hair Restoration Pack- , code 900-2966, contains:
(1) MAYO STAND COVER 23X54
(2) TOWEL CLOTH HUCK BLUE
(2) TABLE COVER BACK ZONE REINFORCED 44 X 90
(2) GOWN SOFT SMS STD. X-LARGE AAMI Ill
(2) TOW...
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1
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08/29/2014
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Customed, Inc
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Z-2516-2014 - Basic Pack FPSC Florham Pack , code 900-2969, contains:
(1) COVER TABLE REINFORCED 50" X 90" (10) GAUZE SPONGE 4" X 4" 16 PLY XRD
(1) COVER MAYO STAND REINFORCED (2) GOWN SOFT SMS STD. X-LARGE AAMI ...
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1
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08/29/2014
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Customed, Inc
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Z-2517-2014 - Chole Cystectomy All Endo System , code 900-3025, contains:
(1) TABLE COVER 44X 90 UF
(1) SYRINGE 20ccW/O NDL LUER LOCK LIF
(2) MAYO STAND COVER REINFORCED UF
(1) NEEDLE HYPODERMIC
(6) ABSORBE...
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1
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08/29/2014
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Customed, Inc
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Z-2518-2014 - Tummy Tuck Pack-BOD , code 900-3026, contains:
(2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII
(2) TOWELS ABSORBENT 15 X 20
(1) PENCIL CAUTERY PUSH BOTTOM
(1) COUNTER NEEDLE/BLADE 20C FOAM/MAG
...
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1
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08/29/2014
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Customed, Inc
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Z-2519-2014 - Face Pack- BOD, code 900-3027, contains:
(2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill
(2) TOWELS ABSORBENT 15" X 20"
(1 ) DRAPE INSTRUMENT MAGNETIC 10" X 16"
(1 ) TRAY HALF DEEP
(1) COUNTER NEE...
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1
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08/29/2014
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Customed, Inc
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Z-2520-2014 - Liposuction Pack BOD, code 900-3028, contains:
(2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill
(2) LITE GLOVES LIF
(2) TOWEL ABSORBENT 15" X 20" L/F
(1) NEEDLE HYPODERMIC 27G X 1 %" LIF
(1) BOWL U...
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1
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08/29/2014
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Customed, Inc
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Z-2521-2014 - Breast Pack BOD, code 900-3029, contains:
(2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMI Ill
(2) TOWEL ABSORBENT 15" X 20"
(1) PENCIL CAUTERY PUSH BOTTOM
(1) SYRINGE BULB 60CC
(1) TUBE SUCTION C...
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1
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08/29/2014
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Customed, Inc
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