🍔 Food 💊 Drugs 🏥 Medical Devices
VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma. Class II

Reason: The firm is recalling the specific lot due to lower than expected results.

Ortho-Clinical Diagnostics 20130401 Terminated
Distributed: Worldwide Distribution-USA (nationwide) including the states of AR, AZ, CA, CO, CT, FL, HI, ID, IL, KY, LA, ME, NJ, OK, TN, TX, WA, and WV, and the countries of Colombia, India, Japan, Mexico, Puerto Rico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.
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BC Hammock Mesh Sling (Junior), product number, 537005. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair. Class II

Reason: The product does not meet the firm's size standards, the product was produced in the incorrect size.

Prism Medical Services USA 20130523 Terminated
Distributed: Worldwide distribution: USA (nationwide) including states of: CA, IL, OH, and TX. and country of: Canada.
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BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair. Class II

Reason: The product does not meet the firm's size standards, the product was produced in the incorrect size.

Prism Medical Services USA 20130523 Terminated
Distributed: Worldwide distribution: USA (nationwide) including states of: CA, IL, OH, and TX. and country of: Canada.
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BC Hammock Mesh Sling (Large), product number, 537030. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair. Class II

Reason: The product does not meet the firm's size standards, the product was produced in the incorrect size.

Prism Medical Services USA 20130523 Terminated
Distributed: Worldwide distribution: USA (nationwide) including states of: CA, IL, OH, and TX. and country of: Canada.
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BC Hammock Mesh Sling (Medium), product number, 537005. Product Usage: Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair. Class II

Reason: The product does not meet the firm's size standards, the product was produced in the incorrect size.

Prism Medical Services USA 20130523 Terminated
Distributed: Worldwide distribution: USA (nationwide) including states of: CA, IL, OH, and TX. and country of: Canada.
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GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6, Volume Share 5 enhanced  vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume Share 5 enhanced  vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response. Class II

Reason: GE Healthcare has recently become aware of a potential safety issue with respect to the automated PERCIST response criteria calculation applied in the PET VCAR application on Advantage Workstation or AW Server.

GE Healthcare, LLC 20130509 Terminated
Distributed: Worldwide Distribution - USA including CA, CO, CT, FL, GA, IL, NY, NY NC OH, TX, VA, WV, WI. Internationally to: AUSTRALIA, AUSTRIA, BAHARIN, CANADA, CHILE, CHINE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GEORGIA, GERMANY, HONG KONG, INDIA, INDONESIA, ITALY, JAPAN, KOREA, MEXICO, MOROCCO, NIGERIA, POLAND, ROMANIA, RUSSIA,SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM.
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IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms Class II

Reason: There was an error on the outer labeling of this device. The inner label was correct.

IDEV Technologies, Inc. 20120529 Terminated
Distributed: Nationwide Distribution to the states of FL, NY, and PA.
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Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides. Class II

Reason: Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. The User Guides should state the devices are for Research Use Only and are not for use in diagnostic procedures.

Aperio Technologies Inc 20130222 Terminated
Distributed: Nationwide Distribution - including all states, none internationally .
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Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain. Class II

Reason: Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin that is intended to hold the guide into place may not come into contact with the bone.

Biomet, Inc. 20130515 Terminated
Distributed: Worldwide Distribution-USA (nationwide) including the states of UT, TX, AL, KY, and WI, and the countries of Australia, The Netherlands, Korea, and Canada.
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Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. Class II

Reason: Biomet Trauma ("Biomet") has initiated a recall of Retrograde Femoral Connecting Bolt, which involves Part Number 14-442021. The connecting bolt has an undersized diameter specification that may cause an interference fit with the 4mm hex driver (Part Number: 41024) near the edge of the tolerance. If the 4mm hex driver becomes stuck in the connecting bolt it cannot be taken apart and a delay in su

Biomet, Inc. 20130429 Terminated
Distributed: Worldwide Distribution - USA Nationwide: CA, TX, NY, PA, NJ, FL, OH, MI, CO, SD, IN, MT, GA, and WI. and the countries of Netherlands, Costa Rica, Japan, and San Juan.
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