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Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Bl... (MWT Materials, Inc.) – when not used correctly, accusorb mri... (2014)

When not used correctly, Accusorb MRI products may overheat and lead to patient injury.

FDAOct 6, 2014Nationwide• MWT Materials, Inc.

Synthes Inflation System (03.804.4135) Product Usage:... (PEROUSE MEDICAL) – additional instructions for use due t... (2014)

Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure

Class IIModerate

FDAOct 6, 2014Nationwide

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Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Bl... (MWT Materials, Inc.) – when not used correctly, accusorb mri... (2014)

Synthes Inflation System (03.804.4135) Product Usage:... (PEROUSE MEDICAL) – additional instructions for use due t... (2014)

UNIVERSAL Modular Electric/Battery Handpiece for surgery ... (Zimmer Surgical Inc) – non-injury complaints from europe ide... (2014)

Bard Caliber (CL3030) Inflation Device Product Usage:... (PEROUSE MEDICAL) – additional instructions for use due t... (2014)

Avastin (Creative Compounds) – sterility concerns (2014)

Glutathione (Creative Compounds) – sterility concerns (2014)

Hyaluronidase Injectable (Creative Compounds) – Sterility Risk (2014)

Omnipaque (Creative Compounds) – sterility concerns (2014)

Mitomycin Injectable (Creative Compounds) – Sterility Risk (2014)

Papaverine HCL Injection (Creative Compounds) – Sterility Risk (2014)

Glutathione (Creative Compounds) – sterility concerns (2014)

Papaverine HCL Mix (Creative Compounds) – sterility concerns (2014)

Gentamicin Sulfate (Creative Compounds) – Sterility Concern (2014)

Papaverine Phentolamine Injection (Creative Compounds) – Sterility Risk (2014)

Laksell Gamma Knife Perfexion (Elekta, Inc.) – elekta has become aware that the latc... (2014)

Triesence (Creative Compounds) – sterility concerns (2014)

Gentamicin Sulfate Irrigation Solution (Creative Compounds) – Sterility Risk (2014)

Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho ... (MWT Materials, Inc.) – when not used correctly, accusorb mri... (2014)

Lidocaine HCL (Creative Compounds) – Sterility Concern (2014)

Alliance Tech Medical, Inc. All Flow Pulmonary Function F... – patients have experienced a bad taste... (2014)