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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-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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Customed, Inc
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Z-2483-2014 - LAP Abdom w/pouch Customed code 900-2619, contains:
(1) DRAPE LAP. ABDOM W/POUCH 102" X 122" X 78"
(1) WRAPPER 30" X 30"
Product Usage:
EO sterilized surgical convenient packs packaged into poly...
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1
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08/29/2014
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Customed, Inc
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Z-2484-2014 - HIP PACK I (2), CUSTOMED, code 900-2504
(1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP
(1) MAYO STAND COVER REINFORCED
(1) U-DRAPE 60" X 70" WITH TAPE SPLIT
(1) STOCKINETTE IMPERVIOUS 12" X 48"
(4) DR...
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1
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08/29/2014
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Customed, Inc
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Z-2485-2014 - Universal Pack II (2) Customed 900-2509
(1) MAYO STAND COVER REINFORCED
(2) DRAPE SIDE 42" X 76" WITH TAPE
(1) DRAPE BOTTOM ABSORBENT REINFORCED 71" X 62" STD SMS WITH TAPE
(1) DRAPE TOP W/ADHESIV...
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1
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08/29/2014
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Customed, Inc
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Z-2486-2014 - Shoulder pack (I) (2), code 900-2515
(1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL Ill
(1) TOWEL ABSORBENT 15" X 20"
(1) GOWN XXL SMS IMPERVIOUS REINFORCED
(1) MAYO STAND COVER REINFORCED
(2) STR...
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1
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08/29/2014
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Customed, Inc
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Z-2487-2014 - Plastic Pack Customed, code 900-2582
(1) GOWN LGE SMS IMP REINF L/F
(1) GOWN SURG. REINF LGE TMJRAP LIF
(1) MAYO STAND COVER REINF LIF
(1) TABLE COVER REINF 50" X 90" LIF (4)
(1) PVP PAINT 8" ...
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1
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08/29/2014
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Customed, Inc
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Z-2488-2014 - Face Pack MRT, product code 900-2654, contains:
(2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF
(2) TOWELS ABSORBENT 15 X 20 LIF
(1) DRAPE INST. MAGNETIC 10 X 16 LIF
(1) TRAY HALF DEEP
(1) COVER ...
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1
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08/29/2014
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Customed, Inc
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Z-2489-2014 - Liposuction Pack MRT, code 900-2656, contains:
(1) NEEDLE HYPODERMIC 27 X 1 LIF
(1) UTILITY BOWL QUART 32oz LIF
(1) MAYO STAND COVER REINFORCED LIF
(2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF...
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1
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08/29/2014
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Customed, Inc
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Z-2490-2014 - Tummy Pack MRT, code 900-2657, contains:
(2) GOWN SOFT SMS STD XLGE SET IN SLEEVE
( 1) CAUTERY PENCIL PUSH BOTTOM
( 1) NEEDLE ULTRACLEAN 1"
(2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK
( 1) NEEDLE &...
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1
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08/29/2014
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Customed, Inc
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Z-2491-2014 - Breast Pack MRT, code 900-2658, contains:
( 1) BULB SYRINGE 60cc
(2) GOWN SOFT SMS STD XLGE SET IN SLEEVE
( 1) CAUTERY PENCIL PUSH BOTTOM
(2) SYRINGE 10cc W/0 NEEDLE LUER LOCK
( 1) NEEDLE and BLA...
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1
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08/29/2014
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Customed, Inc
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