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Showing 63181–63200 of 68218 results

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Respironics, Inc.: Inv Circuit Assembly Box 10 CE model number 652002. Fil...

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

FDAOct 15, 2007Nationwide• Respironics, Inc.

Respironics, Inc.: RP Duet LX/Pro Out Port w/Seal model number 622239. Fil...

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

FDAOct 15, 2007Nationwide• Respironics, Inc.

Respironics, Inc.: RP-REM Auto w/C-FLEX/REM Pro Tubing Kit model number 1008...

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

FDAOct 15, 2007Nationwide• Respironics, Inc.

Respironics, Inc.: Continuous ventilator accessories under the following bra...

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

FDAOct 15, 2007Nationwide• Respironics, 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.: Lead Wire Pin/Socket 24 in 1 pr model number 9520. Filt...

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

FDAOct 15, 2007Nationwide• Respironics, Inc.

Respironics, Inc.: Filters under the following brand names: a) filter std in...

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.

Respironics, Inc.: RP-Leaf, Check valve-5 pk model number F33440. 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 6931 Steroid eluting, tripolar, ...

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.: RP-REMStar Plus Keypad model number 1006852. 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 -- LyfoCults Haemophilus parainfluenzae - micro organ...

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.

Interpore Cross International Inc: InterGro PLUS; DBM in a Lipid Carrier with Calcium Granu...

Unapproved Testing:Interpore Cross International was recently informed that one of its human tissue suppliers, LifeLink Tissue Bank ("LifeLink"), utilized unapproved diagnostic testing (HBsAg & HBc) on certain lots of distributed donor tissue instead of the FDA approved screening test. As a result, Interpore Cross International has initiated a recall on specific lots of products containing human

FDAOct 15, 2007Nationwide• Interpore Cross International Inc

Respironics, Inc.: APNEA monitor accessories under the following brand names...

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

FDAOct 15, 2007Nationwide• Respironics, Inc.

Respironics, Inc.: RP C-Flex Mini Din Plug model number 1011220. Filter, m...

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

FDAOct 15, 2007Nationwide• Respironics, Inc.

Respironics, Inc.: Stardust Flexible Y Sensor Probe model number 612054. F...

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

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