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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-2392-2014 - UMBILICAL VESSEL CATHETER KIT - CUSTOMED-
(1) PAPER TAPE MEASURE DISP. 24"
(1) FENESTRATED DRAPE 18" x 26" LIF
(1) NEEDLE HOLDER BAUMGARTNER 5"
(2) HALSTED MOSQUITO CVD 5" SERRAT
(1) ADSON FORC...
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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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Z-2394-2014 - IMPLANTE DE ORTHOPEDIA -
( I) CAUTERY T IP POLI SHER LIF
( I) BAG SUTURE FLORAL LIF
( I) TUBE SUCTION CONNECT \14'' X 12' LIF
( I) BAG GLASSINE LIF
(2) LITE GLOVE LIF
(2) TABLE COVER 50" X 9...
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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-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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FEI # 2648727 Customed, Inc
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Z-2396-2014 - ANGIOGRAPHY PACK -
(1) LINE H.P. 1200 PSI 48" M/F
(1) ANG. FEMORAL DRAPE WITH POUCH UF
(1) PLATFORM TRAY LARGE
(3) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF
(1) TABLE COVER REINFORCED 50" X 90" ...
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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-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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FEI # 2648727 Customed, Inc
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Z-2398-2014 - CIRUGIA CARDIOVASCULAR - CASE CART -
(1) CIRUGIA CARDIOVASCULAR (PREPARACION)
(1) CIRUGIA CARDIOVASCULAR (ENFERMERA CIRCULANTE)
(1) CIRUGIA CARDIOVASCULAR (INDUCCION)
(1) OPEN HEART TRAY
EO ste...
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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-2399-2014 - LAPAROSCOPY CHOLECYSTECTOMY PACK-
(1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD UF
(2) ABSORBENT TOWELS 15" X 20" UF
(1) MAYO STAND COVER REINFORCED UF
(4) BANDAGE ADHESIVE W' x 3" L I F
(4) DRAPE UTILI...
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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-2400-2014 - UROLOGY PACK-
(10) GAUZE SPONGE 4" X 4" 16PLY
(1) TUBE SUCTION CONNECT Y." X12'
(1) SYRINGE 30cc WITHOUT NEEDLE ULOCK
(1) BASIN RING
(1) TUR Y SET, 2 LEAD, ST.
(1) BAG SUTURE FLORAL
(1) GOW...
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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-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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FEI # 2648727 Customed, Inc
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