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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-2422-2014 - ENDOVENOUS CUSTOM PACK - CUSTOMED
(1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F
(1) Pr. GLOVE SYNTEGRA CR # 7.5 P/F LIF
(2) Pr. GLOVE SYNTEGRA CR # 6.5 P/F LIF
(20) GAUZE SPONGE 4" X 4" 12PL Y LI...
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1
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08/29/2014
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Customed, Inc
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Z-2471-2014 - EENT PACK I
CUSTOMED
CONTENT:
(2) TOWEL ABSORBENT 15" X 20"
(1) MAYO STAND COVER REINFORCED (1) BAG SUTURE FLORAL
(1) SHEET ENT SPLIT 110" X 77" SMS
(1) TABLE COVER REINFORCED 50" X 9...
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1
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08/29/2014
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Customed, Inc
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Z-2455-2014 - EAR PACK
CONTENTS:
(I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc
(2) LABEL FOR SKIN MARKERS
( I) NEEDLE HYPODERMIC 1 80 X I Y,
( I) WASI-l BASIN ROUND 6QT...
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1
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08/29/2014
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Customed, Inc
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Z-2442-2014 - EAR PACK
CONTENTS:
( I ) B LADE SU RG ICA L # 15 CARBON STEEL
( I ) EMESI S BASIN lO in 700cc
( I ) GOWN XL SMS IM P. REINFORCED
( I ) NEEDLE HYPODERM IC 1 8G X I 'h
( I ) WASH BAS...
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1
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08/29/2014
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Customed, Inc
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Z-2395-2014 - E..N.T. PACK -
(5) SPONGE TONSIL 7/8 XRD
(1) TABLE COVER REINFORCED 50" X 90" LIF
(1) MAYO STAND COVER REINFORCED L/F
(1) TUBE SUCTION CONNECT %" X 12' L/F
(1) CAUTERY TIP POLISHER LIF
(1) SUTU...
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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-2401-2014 - DRESSING CHANGE - CUSTOMED-
(2) GLOVE MED. FREETOUCH VYNIL POWDER FREE
( I) DRESSING TEGADERM 3 Y2 X 4 Y2
( I) MASK PROCEDURAL YELLOW 80MM HG L/F
(4) GAUZE 4" X 4" 4PLY
( I) ALCOHOL PREP PAD...
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1
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08/29/2014
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Customed, Inc
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Z-2397-2014 - D & C LAPAROSCOPY PACK -
(1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT
(1) MAYO STAND COVER REINFORCED UF
(4) DRAPE UTILITY UF
(1) TRAY MAYO SMALL LIF
(1) SPECIMEN CONTAINER 4oz. WITH LID & LABE...
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1
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08/29/2014
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Customed, Inc
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Z-2303-2014 - Customed O.B. Pack
convenience pack include multiple components: set up cover, absorbent towel, ear ulcer syringe, pad, umbilical cord clamp, wash basin, baby blankets, table cover, gauze sponge, sy...
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1
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08/29/2014
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Customed, Inc
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Z-2305-2014 - Customed Major Laparotomy Pack , convenience pack include multiple components: Mayo stand cover, absorbent towel, bag suture, drape, suction tube, lite glove, gauze/sponges, drape, surgical blades, ut...
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1
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08/29/2014
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Customed, Inc
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