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Showing 20001–20020 of 22584 results

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Lifescan Inc: LifeScan OneTouch SureSoft Lancing Device, single use lan...

In some cases, the needles in the single use lancing device may not retract, causing a potential for needle sticks.

FDAOct 11, 2005IN• Lifescan Inc

Lifescan Inc: LifeScan OneTouch Ultra Primary Care Physician Demo Kits,...

Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters

FDAOct 10, 2005Nationwide• Lifescan Inc

Medrad Inc: Stellant CT Injection System. Powered Injector with Syrin...

the heat maintainer, an accessory, may overheat and deform the disposable syringe

FDAOct 10, 2005Nationwide• Medrad Inc

Abbott Laboratories: Fleixiflo Quantum Enteral Pump.

Pumps have the potential to malfunction and result in a significant over-under delivery of enteral formula.

FDAOct 7, 2005AL, CA, IN +12 more• Abbott Laboratories

Invision Technologies Inc: CTX 5500 DS and CTX 2500 Explosive Detection Systems (EDS...

X-ray leakage exceed exposure standard of 0.5 mR/hr.

FDAOct 7, 2005Nationwide• Invision Technologies Inc

Medrad Inc: Medrad Overhead Counterpoise System II. Support Arm. Moun...

overhead system can fall due to the failure of a retaining ring.

FDAOct 7, 2005Nationwide• Medrad Inc

Unknown Manufacturer: Photo Micro VR/DR Models V-232

Vendor-supplied memory chip in a limited number of St. Jude Medical ICDs can trigger a temporary loss of pacing function and permanent los of defibrillation support.

FDAOct 6, 2005Nationwide

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1, 4 inch diameter Rolle...

An incorrect serial number was placed on one roller pump.

FDAOct 6, 2005MI• Terumo Cardiovascular Systems Corp

Cobe Cardiovascular, Inc: Custom heart lung perfusion packs

One way valve in the heart lung pack assembly may be missing.

FDAOct 6, 2005CA, CO, FL +4 more• Cobe Cardiovascular, Inc

Unknown Manufacturer: Photo Micro VR/DR Models V-194

Vendor-supplied memory chip in a limited number of St. Jude Medical ICDs can trigger a temporary loss of pacing function and permanent los of defibrillation support.

FDAOct 6, 2005Nationwide

Unknown Manufacturer: Photo DR, Model V-230HV Implantable Cardioverter Defibril...

Vendor-supplied memory chip in a limited number of St. Jude Medical ICDs can trigger a temporary loss of pacing function and permanent los of defibrillation support.

FDAOct 6, 2005Nationwide

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1, 6 inch diameter Rolle...

Six inch roller pumps were mislabeled as 4 inch roller pumps.

FDAOct 6, 2005MI• Terumo Cardiovascular Systems Corp

Unknown Manufacturer: Atlas DR, Models V-240

Vendor-supplied memory chip in a limited number of St. Jude Medical ICDs can trigger a temporary loss of pacing function and permanent los of defibrillation support.

FDAOct 6, 2005Nationwide

Louisville Apl Diagnostics Inc: APhL HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distribute...

Mislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.

FDAOct 6, 2005CA, FL, GA +1 more• Louisville Apl Diagnostics Inc

Unknown Manufacturer: Atlas VR, Models V-199

Vendor-supplied memory chip in a limited number of St. Jude Medical ICDs can trigger a temporary loss of pacing function and permanent los of defibrillation support.

FDAOct 6, 2005Nationwide

Louisville Apl Diagnostics Inc: APhL HRP IgG ELISA Kit; Ref. #LAPL-K-HRP-001G; distribute...

Mislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.

FDAOct 6, 2005CA, FL, GA +1 more• Louisville Apl Diagnostics Inc

Louisville Apl Diagnostics Inc: APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; dist...

Mislabeing : Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.

FDAOct 6, 2005CA, FL, GA +1 more• Louisville Apl Diagnostics Inc

Siemens Medical Solutions USA, Inc: Breast Biopsy Aiming Device. Magnetic Resonance Imaging S...

If the recommended workflow is not followed and the worksheets are printed after moving the patient table out of isocenter, the offset values will be incorrect. This could result in a biopsy being performed at an incorrect location and presents the possibility of an inconclusive diagnosis. calculation of offset values for the breast biopsy aiming device may be incorrect

FDAOct 5, 2005CA, FL, IL +8 more• Siemens Medical Solutions USA, Inc

Heartsine Technologies Inc: HeartSine Samaritan AED Defibrillators Models: SAM 001, S...

Immediately after battery installation the devices announce a low battery fault warning and shut themselves off, or the service indicator icon starts blinking indicating a fault condition.

FDAOct 5, 2005Nationwide• Heartsine Technologies Inc

Advanced Medical Optics, Inc.: Tecnis Monofocal Silicone Posterior Chamber IOLs (Models:...

A small opening (channel or tunnel) in the seal of the outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.

FDAOct 5, 2005Nationwide• Advanced Medical Optics, Inc.

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