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Showing 17521–17540 of 22534 results

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Respironics, Inc.: Power Supply under the following brand names: a) RP, Powe...

Foreign material: Glass fragments may present in the plastic bag material used to ship components.

FDAOct 15, 2007Nationwide• Respironics, Inc.

Respironics, Inc.: Mouthpiece, Angled 22mm CE model number FC06566. Filter...

Foreign material: Glass fragments may present in the plastic bag material used to ship components.

FDAOct 15, 2007Nationwide• Respironics, Inc.

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Sprint Fidelis 6948 Steroid eluting, quadripola...

Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). Medtronic, its Independent Physician Quality Panel, and Bruce Lindsay, M.D., Professor of

FDAOct 15, 2007PR• Medtronic Inc. Cardiac Rhythm Managment

Respironics, Inc.: Omni Lab Core Domestic model number 1043343. Filter, ma...

Foreign material: Glass fragments may present in the plastic bag material used to ship components.

FDAOct 15, 2007Nationwide• Respironics, Inc.

PML, Inc. dba Pml Microbiologicals Inc.: PML --IDS Rapid NH QC Set- Quality Control kit for cultur...

Incorrect micro-organism-- .Quality control In-vitro diagnostic test was manufactured with Cryptococcus neoformans (ATCC 76484) instead of Haemophilus parainfluenzae (ATCC 7901).

FDAOct 15, 2007Nationwide• PML, Inc. dba Pml Microbiologicals Inc.

Respironics, Inc.: ECG Lead Set 60 in SOC to Snap model number 8049-1. Fil...

Foreign material: Glass fragments may present in the plastic bag material used to ship components.

FDAOct 15, 2007Nationwide• Respironics, Inc.

Respironics, Inc.: Non-continuous ventilators under the following brand name...

Foreign material: Glass fragments may present in the plastic bag material used to ship components.

FDAOct 15, 2007Nationwide• Respironics, Inc.

Respironics, Inc.: Breathing Frequency Monitor Stardust 2 Domestic model num...

Foreign material: Glass fragments may present in the plastic bag material used to ship components.

FDAOct 15, 2007Nationwide• Respironics, Inc.

Haemonetics Corporation: Haemonetics cardioPAT System, Product List Number 02050, ...

Labeling (additional) use instructions: to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient's chest

FDAOct 15, 2007Nationwide• Haemonetics Corporation

Respironics, Inc.: Non-continuous ventilator accessories under the following...

Foreign material: Glass fragments may present in the plastic bag material used to ship components.

FDAOct 15, 2007Nationwide• Respironics, Inc.

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Sprint Fidelis 6949 Steroid eluting, quadripola...

Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). Medtronic, its Independent Physician Quality Panel, and Bruce Lindsay, M.D., Professor of

FDAOct 15, 2007PR• Medtronic Inc. Cardiac Rhythm Managment

PML, Inc. dba Pml Microbiologicals Inc.: PML -- Vitek NH ID Card (NHI) Set - Quality Control kit ...

Incorrect micro-organism-- .Quality control In-vitro diagnostic test was manufactured with Cryptococcus neoformans (ATCC 76484) instead of Haemophilus parainfluenzae (ATCC 7901).

FDAOct 15, 2007Nationwide• PML, Inc. dba Pml Microbiologicals Inc.

Respironics, Inc.: BIPAP AUTO, CORE PACKAGE NA, model number 1017442, filter...

Foreign material: Glass fragments may present in the plastic bag material used to ship components.

FDAOct 15, 2007Nationwide• Respironics, Inc.

Abbott Laboratories Inc.: Abbott Clinical Chemistry Creatine Kinase, Model LN 7D63-...

Three potential issues with Creatine Kinase Lot Number: 52044HW00: (1) Decrease in quality control and/or patient results (2) An iIncreased imprecision, or (3) Error Code 1054 (Unable to calculate results, Reaction Failure) on Architect cSystems.

FDAOct 12, 2007Nationwide• Abbott Laboratories Inc.

Boston Scientific Corporation One Boston: Boston Scientific, Imager II Angiographic Catheter, (Oute...

Mislabeled: Units within the identified lot/batch were incorrectly labeled as 5F on the outer carton and pouch when the product was actually a 4F device.

FDAOct 12, 2007AZ, CA, NJ +1 more• Boston Scientific Corporation One Boston

Microbiologics Inc: MicroBiologics; P. vulgaris, DuoPacksl Product Catalog N...

Mislabeled: DuoPacks of Proteus vulgaris contained Listeria monocytogenes instead of the labeled Proteus vulgaris.

FDAOct 12, 2007AZ, CA, GA +8 more• Microbiologics Inc

Invacare Corporation: CareGuard Mattress Models CG10180 and CG10180A used with ...

In October 2007 Invacare Corporation, Florida recalled CareGuard Mattresses, Models CG10180 and CG10180A, associated with IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the ValueCare Bed Series Semi Electric Beds, when used with Invacare bed rails. Affected bed packages are BED24IVC, BED25IVC, BED24CA, and BED25CA. The mattresses when used in combination with the IVC a

FDAOct 11, 2007Nationwide• Invacare Corporation

Beckman Coulter Inc: Cytomics FC 500 Flow Cytometry System with CXP Software V...

Software error: This field action was initiated after Beckman Coulter determined that the CXP software does not refresh the dataset automatically under certain circumstances. The User documentation does not clearly state that the user should refresh the dataset after changes are made.

FDAOct 11, 2007Nationwide• Beckman Coulter Inc

Nonin Medical, Inc: Nonin Model 2500 PalmSAT handheld pluse Oximeter , Nonin ...

Incorrect Label: The label on the back of the device may show Model 2500A rather than Model 2500.

FDAOct 11, 2007CA, CT, FL +10 more• Nonin Medical, Inc

Abbott Laboratories, Inc: Abbott ACCELERATOR APS System Input/Output Module (IOM); ...

Sample problems; Five issues identified related to software utilized by the ACCELERATOR APS System Input/Output Module, to include: Under three specific conditions, the post-aspiration radio-frequency identification (RF ID) read of the tube carrier is not performed and the APS work cell may not appropriately generate Sample Presentation/Sample Queue errors with APS software version 1.1.1 or earlie

FDAOct 10, 2007Nationwide• Abbott Laboratories, Inc

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