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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-2388-2014 - PEDIATRIC LAP PACK -
( I) SHEET MINOR LAP 102" X 121" X 78"
( I) MAYO STAND COVER REINFORCED LIF
( I) TABLE COVER REINFORCED 50" X 90" LIF
(2) DRAPE SHEET 41 " X 58" SMS
(2) TOWELS ABSORBENT 15"...
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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-2531-2014 - Open Heart Tray, Pack A, code 900-1196C, contains:
(1) TABLE COVER REINFORCED L/Free
(1) CARDIOVASCU.LAR INCISE DRAPE L/Free
(2) 3/4 ABS. REINFORCED SHEET
(1) PLASTIC SHEET
(5) DRAPE SHEET 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-2482-2014 - Open Heart Pack, code 900-2618, contains:
(9) DRAPE 60" X 76" REINFORCED LIF
( 1) MAYO STAND COVER REINFORCED LIF
(6) TOWELS ABSORBENT 15" X 20" L/F
( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAG...
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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-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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FEI # 2648727 Customed, Inc
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Z-2432-2014 - ORTHOPEDIC SURGICAL PACK
HOSPITAL SAN CRISTOBAL
CONTENTS:
(I) CAUTERY TIP POLISH ER LIF (1) BAG SUTURE FLORAL
(1) TUBE SUCTION CONNECT W' X 1 2' LIF
(1) BAG GLASSINE (2) LITE GLOVE
(...
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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-2473-2014 - ORTHOPEDIC PACK Ill (1) CUSTOMED
CONTENTS:
(1) GOWN XL SMS IMPERVIOUS REINFORCED (4) DRAPE UTILITY WffAPE (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG FLORAL
(1) DRAPE TOP W/ADHESIVE 108" ...
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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-2472-2014 - ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains:
(2) TOWELS ABSORBENT 15" X 20" LIF
(1) COVER MAYO STAND REINFORCED L/F
( 1) U- DRAPE 60" X 70" W/TAPE SPLIT 6 X 21LIF
(1) DRAPE % ECONOMY 53" X ...
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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-2507-2014 - ORTHOPEDIC PACK BASIC
CODE 900-2830.
CONTENTS:
(3) TOWELS ABSORBENT 15" X 20"
(1) COVER MAYO STAND REINFORCED
(1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21 SPLIT (1) DRAPE% ECONOMY 53" X 77"
...
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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-2509-2014 - ORTHOPEDIC IMPLANT
PACK CUSTOMED USA, CODE 900-2903
CONTENTS:
(1) CAUTERY TIP POLISHER UF
(1) SKIN MARKER W/RULER
(1) BAG SUTURE FLORAL
(1) U - DRAPE 60" X 70" WITAPE SPLIT 6" X 2...
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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-2452-2014 - ORTHO PACK EXTREMITY
CUSTOMED
CONTENTS:
(1) TABLE COVER REINFORCED 50" X 90" (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG FLORAL
(1) STOCKINETTE IMPERVIOUS 14" X 48"
(1) U-DRAPE 60" X 7...
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1
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08/29/2014
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FEI # 2648727 Customed, Inc
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