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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-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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Z-2453-2014 - VAGINAL PROCEDURE PACK
CUSTOM ED
CONTENTS:
(1) DRAPE LITHOTOMY 110" X 63" W/LEGGINGS I POUCH FEN 3 X 6 SMS LIF (1) GOWN XL SMS IMPERV. REINFORCED LIF
(1) COVER MAYO STAND REINFORCED L...
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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-2454-2014 - TOTAL HYCTERECTOMY
(I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM
(I) TROCAR 5MM BLADELESS W/STAB SLEEVE LIF ( I) NEEDLE ULTRA VERES 120MM LIF
( I) TUBING INSUFFLAT ...
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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-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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FEI # 2648727 Customed, Inc
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Z-2456-2014 - EXTREMITY ARM PACK
CONTENTS:
(1) STOCKINETTE IMPERVIOUS 14" X 48"
(1) GOBAN SELF-ADHERENT WRAP 6" X 5yds
(3) BANDAGE ELASTIC 4" X 5yds
(1) BANDAGE ESMARK 6" X 9
(1) UTILITY BOWL QUART 3...
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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-2457-2014 - CENTRAL LINE DRAPE PACK
1) MASK PROCEDUAL EAR LOOP 120MM HG V/B L/Free
(1) DRAPE SHEET 41" X 58" SMS L/Free
(1) CAP NURSE 21" GREEN BOUFFANT
(1) DRAPE BRACHIAL ANGlO 44" X 31" REINFORCED C...
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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-2458-2014 - KNEE ARTHROSCOPY PACK 4
CUSTOMED
CONTENTS:
(1) COVER TABLE REINFORCED 50" X 90"
(1) GOWN SURG REINFORCED LARGE TOWEL WRAP AAMI LEVEL Ill
(1) PRE PAD CUFF
(1) COVER MAYO STAND REINFORCED
...
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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-2459-2014 - 08 PAD PACK II (2,3)
CUSTOMED
CONTENTS:
(3) TOWEL ABSORBENT 15" X 20" (1) BOWL W/LID PLASTIC 80oz (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) SHEET PLASTIC 44" X 65" (1) DRAPE UNDERBUTTOCK W/POUC...
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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-2460-2014 - BASIC PACK IV (6) CUSTOMED
CONTENTS:
(3) TOWELS ABSORBENT 15" X 20"
(1) MAYO STAN COVER REINFORCED (1) DRAPE % ECONOMY 53" X 77"
(1) DRAPE SHEET 41" X 58" SMS
(4) UTILITY DRAPE W/TAPE (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-2461-2014 - BASIC PACK 1 (Ill) CUSTOMED
CONTENTS:
(1) TABLE COVER REINFORCED 44" X 78" (4) DRAPE UTILITY WffAPE
(2) TOWELS ABSORBENT 15" X 20" (1) SUTURE BAG FLORAL
(1) DRAPE SHEET 42" X 57" SMS
(1) SHEET ...
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1
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08/29/2014
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FEI # 2648727 Customed, Inc
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