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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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Z-0558-2009 - Guidewires - Endoscopic (Jag Wires) Model #'s: MIC5658 and MIC630-100 Intended to be used for selective cannulization of the billary ducts, including but not limited to, the common bile, cystic... 2 Jan-13-2009 Sterilmed Inc
Z-0556-2009 - External Fixation Device Model #'s: ORT99-36501 SYN390.005 SYN390.008 SYN394.84 SYN394.85 and SYN394.86 Intended for use in the construction of an external fixation frame for treatment of a v... 2 Jan-13-2009 Sterilmed Inc
Z-0550-2009 - Burrs Model #'s: ANSL-3SB ANSL-5D ANSQD11-4OVDC HAL5056-118 HAL5056-166 HAL5091-106 HAL5091-112 HAL5091-122 HAL5091-125 HAL5091-136 HAL5091-144 HAL5091-164 HAL5092-120 HAL5092-168 HA... 2 Jan-13-2009 Sterilmed Inc
Z-0560-2009 - Lap Instruments/Graspers/Forceps - HOT Model #'s: AUT173016 AUT174301 AUT176643 AUT176643 ETH5DCD ETH5DCS ETHEBF01 ETHPOUCH GYR3000PK GYR3005PK GYR3640 and GYR920005PK Laparoscopic ... 2 Jan-13-2009 Sterilmed Inc
Z-0562-2009 - Laser Probe Model #': SYN55.26.25 Reprocessed laser probes are part of a laser delivery system and are used in opthalmic procedures where laser energy is the mode of treatment. 2 Jan-13-2009 Sterilmed Inc
Z-0566-2009 - Rasps Model #'s: KOMKM5100-37-113 KOMKM-82 STR1675-115 STR5100-37-113 and STR5100-37-115 A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated devic... 2 Jan-13-2009 Sterilmed Inc
Z-0574-2009 - Open & Unused Items - This refers to a sterilization service provided by by SterilMed, Inc. (devices were not reprocessed) for Class 1 and Class 2 devices that were opened, most likely in O. R. suite... 2 Jan-13-2009 Sterilmed Inc
Z-0546-2009 - Balloon Inflation Device Model #'s: MED15-105 MED15-106 and SCI04527-01 The reprocessed Balloon inflation device is intended for use with balloon dilatation catheters to create and monitor p... 2 Jan-13-2009 Sterilmed Inc
Z-0575-2009 - Biopsy Forceps, Cold Model #'s: BAR000386 BAR000388 MIC1012 MIC1331 MIC1333 MIC1337 MIC1536 MIC1589 MIC1597 MIC1598 and MIC1599 The Reprocessed Cold Biopsy Forceps are intended to be use... 2 Jan-13-2009 Sterilmed Inc
Z-0570-2009 - Scissor Tips Model #'s: AESPO888 AESPO889 ENCES0102 MIC3112 MIC3122 MIC3142 MIC3152 SNO89-5100 and SNO89-5300 Intended to be used with a resusable hand piece and are designed to use in mi... 2 Jan-13-2009 Sterilmed Inc
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