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Showing 22341–22360 of 22623 results

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Henry Schein, Inc.: Positive Touch (TM) TEXTURED POWDER-FREE LATEX EXAM GLOVE...

FDA's analysis revealed defects (holes) in the latex gloves.

FDAJun 27, 2003CT, IN, ME +7 more• Henry Schein, Inc.

Depuy Orthopaedics, Inc.: ProVision Barrier Universal Hood/Gown; product 5431-33-000

Lack of assurance of sterility, due to the possibility of an incomplete package seal.

FDAJun 27, 2003Nationwide• Depuy Orthopaedics, Inc.

Cardinal Health: Catalog SBA35GSMOG, Sterile General Surgery Pack, Mfg dat...

The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized.

FDAJun 27, 2003MN, MO, NJ +1 more• Cardinal Health

Boston Scientific Corporation: Wallstent Enteral Endoprothesis with Unistep Plus Deliver...

Mislabeled: Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm

FDAJun 26, 2003CO, FL, IL +4 more• Boston Scientific Corporation

Numed Inc: CP STENT (Cheatham Platinum), a prescription device, comp...

Lacks a PMA or 510k.

FDAJun 26, 2003IN• Numed Inc

Roche Diagnostics Corp.: MagNA Pure LC Instrument; Catalog number 2236931.

A software bug in version 3.0 may result in prolonged mixing time, evaporation of elution volume and biased sample results for various protocols.

FDAJun 26, 2003Nationwide• Roche Diagnostics Corp.

Hardy Media Inc Dba Hardy Diag: Blood Agar Plates, 5%, Lot 3155A.

Customers complained of bacterial contamination of lot A10-3155A.

FDAJun 25, 2003Nationwide• Hardy Media Inc Dba Hardy Diag

Coopervision Inc: SOFT CONTACT LENSES (toric) packaged under the following ...

The actual sphere power of the lens is lower than the labeled value.

FDAJun 25, 2003Nationwide• Coopervision Inc

Datascope Corp: Anestar Anesthesia Delivery System

Failure of the Anestar AC Main Power Switch. Battery should last 30 minutes, then ventilation and monitoring will fail.

FDAJun 24, 2003Nationwide• Datascope Corp

Guidant Corp-Cpi Division: Pulsar Max II Multiprogrammable Pacemaker, Model 1180

Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.

FDAJun 23, 2003Nationwide• Guidant Corp-Cpi Division

Boston Scientific Corporation: Fibered Platinum Coil, 0.035 Type, 4 mm x 30 mm Catalog...

Product 's Outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa

FDAJun 23, 2003Nationwide• Boston Scientific Corporation

Encision, Inc.: EM2 NC AEM Monitor (NON-COM)

Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.

FDAJun 23, 2003CA, IL, KS +5 more• Encision, Inc.

Beckman Coulter Inc: Power Processor Aliquot Tube Labels Part 800255

Labels are missing an expiration date and storage instructions, increasing the likelihood that they will not be used by the expiration date or may be stored under conditions that would cause adhesive failure and loss of identity of sample or aliquot during testing.

FDAJun 23, 2003Nationwide• Beckman Coulter Inc

Misys Healthcare Systems: Misys Laboratory System versions5.3 up to 5.3.2 with LabA...

Software defect. When Quality Assurance failure warnings are missing from a patient's report abnormal results could be used for diagnosis or treatment.

FDAJun 23, 2003Nationwide• Misys Healthcare Systems

Guidant Corp-Cpi Division: Discovery II Multiprogrammable Pacemaker, Model 0481

Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.

FDAJun 23, 2003Nationwide• Guidant Corp-Cpi Division

Encision, Inc.: EM2+A NC AEM Monotor (NON-COM)

Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.

FDAJun 23, 2003CA, IL, KS +5 more• Encision, Inc.

Deltec, Inc: Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Re...

Pump keyboard entries by the patient could have resulted in the patient having unintended access to programming screens and led to in improper drug dosage.

FDAJun 23, 2003IN, NC, WA• Deltec, Inc

Encision, Inc.: EM2M NC AEM Monitor, (NON-COM)

Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.

FDAJun 23, 2003CA, IL, KS +5 more• Encision, Inc.

Zoll Medical Corporation: Zoll M Series External Defibrillator

Defibrillator may fail to charge or hold its charge above energies of 75 joules

FDAJun 23, 2003Nationwide• Zoll Medical Corporation

Hill-Rom, Inc.: Hill-Rom Newborn bassinet; model P247

The caster/wheel may come off of the bassinet, causing the bassinet to tip.

FDAJun 20, 2003Nationwide• Hill-Rom, Inc.

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