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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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FEI # 2648727 Customed, Inc
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Z-2423-2014 - HIGADO & PANCREA PACK -
(1) BAG SUTURE FLORAL
(2) YANKAUER SUCTION TUBE WITHOUT VENT
(4) DRAPE UTILITY WITH TAPE
(6) TOWELS CLOTH HUCK BLUE
(1) SHEET DRAPE 41 " X 58" SMS
(1) MAYO TRAY LARGE...
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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-2424-2014 - LAPAROSCOPY PACK -
( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F
( 1) NEEDLE ULTRA VERES 120MM LIF
( 1) TROCAR ENDOPATH XCEL DILATING TIP (K11LT) LIF
( 1) TROCAR ENDO.XCEL DILATING TIP (KSLT) LIF
(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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Z-2425-2014 - TRAATEK NEURO PACK
(4)TOWEL ABSORBENT 15" X 20" LIF
( 1) MAYO STAND COVER REINFORCED LIF
( 1) CAUTERY TIP POLISHER LIF
(8) TOWEL CLOTH HUCK (BLUE)
( 1) BULB SYRINGE 60cc LIF
( 1) TABLE COVER 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-2426-2014 - SHOULDER PACK- CUSTOMED-
(1) TABLE COVER REINFORCED 50" x 90" LIF
(2) MAYO STAND COVER REINFORCED L/F
(1) U-DRAPE 60" X 70" WITH TAPE SPLIT
(4) TOWELS ABSORBENT 15" X 20" LIF
(4) DRAPE UTILITY ...
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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-2427-2014 - O.B. PACK -
( I) PVP SCRUB 8" STICK SPONGES
( I) UNDERBUTTOCK DRAPE WITH POUCH
(2) LEGGINS WITH 7" CUFF 30" x 42"
( I) DRAPE ABDOMINAL WITH TAPE LIF
( I) VAGINAL PACKING SPONGEXRD
( I) BOWL WIT...
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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-2428-2014 - GENERAL PACK -
CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF
(1) MAYO STAND COVER REINFORCED LIF
( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF
(2) UTILITY BOWL 16 oz. LIF
(1) GLASINE BAG PLAIN
( 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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Z-2429-2014 - LAPAROSCOPY CHOLE PACK -
(6) TOWELS ABSORBENT 15" X 20" LIF
(1) MAYO STAND COVER REINFORCED L/F
(1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF
(1) SURGICAL BLADE #11 CARBON STEEL
(1) TUR Y SET, 2L...
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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-2430-2014 - CESAREAN PACK -
(1) BABY BLANKET IMP. POLY ABS.
(4) ABSORBENT TOWELS 15" x 20" LIF
(2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF
(2) LITE GLOVES LIF
(1) BOWL PLASTIC WITH LID 80 oz.
(1) C-SEC...
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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-2431-2014 - ANGIOGRAPHY PACK
CONTENTS:
(4) CLOTH HUCK TOWEL BLUE
(1) TABLE COVER REINFORCED 50" x 90" LIF
(2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (2) CUP MEDICINE 2oz LIF
(2) UTILITY BOWL 32oz LIF
(...
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1
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08/29/2014
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FEI # 2648727 Customed, Inc
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