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Showing 68021–68040 of 68218 results

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Cryolife Inc: CryoValve Pulmonary Valve & Conduit.

Microorganisms detected in associated allografts.

FDAMay 23, 2003CT, IN, MT• Cryolife Inc

Medtronic Physio Control Corp: LIFEPAK CR Plus defibrillator

Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy.

FDAMay 23, 2003Nationwide• Medtronic Physio Control Corp

Unknown Manufacturer: Weck Electrosurgical Coagulation Suction Tube (with styl...

Some stylets were not bent sufficiently during the packaging process to preclude them from sliding back into the cannula during shipment.

FDAMay 21, 2003Nationwide

Ethicon Endo-Surgery: Proximate Linear Cutter with Safety Lock-Out, Reloadable,...

Laceration Risk

The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly.

FDAMay 21, 2003Nationwide• Ethicon Endo-Surgery

GE Medical Systems Information Technologies: GE Medical Systems COROMETRICS Maternal/Fetal Monitoring ...

The 2120 Main Board on device lacks required external safety 'watchdog' circuit.

FDAMay 21, 2003CA, IN, MD +5 more• GE Medical Systems Information Technologies

Beckman Coulter Inc: Synchron Systems Prealbumin Reagent Part Number: 475106

Instability leading to falsely elevated patient results, out of range controls, or error code.

FDAMay 20, 2003Nationwide• Beckman Coulter Inc

Merit Medical Systems, Inc: Inject 10 Coronary Control Syringe (CCS), 10ml

Cracks in the syringe barrels could allow for air aspiration into the syringe barrel.

FDAMay 16, 2003Nationwide• Merit Medical Systems, Inc

Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom: Portex Uncuffed Nasal Tracheal Tubes, Ivory 5mm x 25cm ...

Tracheal tubes may be non-sterile

FDAMay 16, 2003Nationwide• Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom

Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom: Portex Uncuffed Oral Tracheal Tubes, Siliconized 6mm x 19...

Tracheal tubes may be non-sterile

FDAMay 16, 2003Nationwide• Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom

Merit Medical Systems, Inc: Custom Kit

Cracks in the syringe barrels could allow for air aspiration into the syringe barrel.

FDAMay 16, 2003Nationwide• Merit Medical Systems, Inc

Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom: Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 3m...

Tracheal tubes may be non-sterile

FDAMay 16, 2003Nationwide• Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom

Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom: Portex Tracheal Tube Profile Soft-Seal Cuff, Ivory Nasal ...

Tracheal tubes may be non-sterile

FDAMay 16, 2003Nationwide• Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom

Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom: Portex Profile Soft-Seal Cuff Oral/Nasal Tracheal Tube, ...

Tracheal tubes may be non-sterile

FDAMay 16, 2003Nationwide• Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom

Den-Tal-Ez Inc, Star Dental Div: Portable HDX Intraoral Dental X-Ray. Extraoral Source X-r...

problems with product label

FDAMay 16, 2003IL, IN, MD +3 more• Den-Tal-Ez Inc, Star Dental Div

Health Care Manufacturing Inc: HCMI operator control panels for chiropractic x-ray syst...

Required labeling (certification and manufacturer's label) was missing from the Operator Control Panels

FDAMay 15, 2003Nationwide• Health Care Manufacturing Inc

Abbott Laboratories HPD/ADD: T-U-R Y-Set Non-Vented Set for Transurethral Resection Pr...

The irrigation set was mislabeled with the wrong delivery rate of 8 drops/mL when it actually has a delivery rate of 11 drops/mL

FDAMay 13, 2003LA• Abbott Laboratories HPD/ADD

Sanarus Medical Inc: Sanarus brand Centrica Rotational Core Biopsy medical dev...

Recent 'pre-tests' show that Argon gas has the potential to escape from the device during a biopsy procedure.

FDAMay 13, 2003IL, MD, OH +3 more• Sanarus Medical Inc

Misys Healthcare Systems: Misys Laboratory System, version 5.3

Two clients reported Quality Assurance dates could not be entered after 5/19/03.

FDAMay 13, 2003Nationwide• Misys Healthcare Systems

Abbott Laboratories HPD/ADD: LifeShield Latex-Free Microdrip Soluset 100 mL Burette Pl...

IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.

FDAMay 13, 2003Nationwide• Abbott Laboratories HPD/ADD

Abbott Laboratories HPD/ADD: LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 ...

IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.

FDAMay 13, 2003Nationwide• Abbott Laboratories HPD/ADD

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