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Showing 21041–21060 of 22584 results

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Kendall Healthcare Products Co: Curity Pediatric Lumbar Puncture Tray with Safety Compone...

Needle cannula may separate from the hub during use

FDAOct 8, 2004Nationwide• Kendall Healthcare Products Co

International Chemical Inc.: OTC Pregnancy Test labeled ''CHOICE Pregnancy Test Kit''...

Poor sealing of pouches and degradation of product. Invalid test results and false negatives are possible.

FDAOct 7, 2004FL, IN• International Chemical Inc.

International Chemical Inc.: OTC Pregnancy Test Kit labeled: ''CHOICE Pregnancy Test K...

Poor sealing of pouches and degradation of product. Invalid test results and false negatives are possible.

FDAOct 7, 2004FL, IN• International Chemical Inc.

Chembio Diagnostic System Inc: OTC Pregnancy Tests. Name: Sure Check hCG Midstream Pregn...

Poor sealing of pouches and degradation of products. Firm received an e-mail from a distributor of an increase in complaints. In response to the complaints, the distributor conducted its own functional testing and noticed a degradation in performance of the two lots. Chembio's investigation revealed invalid results (no control lines) and some false negatives.

FDAOct 6, 2004FL, IN, KS +8 more• Chembio Diagnostic System Inc

Toshiba American Med Sys Inc: Magnetic Resonance Imaging Systems under the following na...

Software defect causes images to be rotated 180 degrees.

FDAOct 6, 2004Nationwide• Toshiba American Med Sys Inc

Lone Star Medical Products, Inc: Lone Star Medical Products, Inc. 1100 Series Aluminum Ret...

Ni-Cr Plated 1100 Series Retractors with a chromium finish were replaced by Retractors with a hard-anodized finish after complaints of peeling were received.

FDAOct 6, 2004Nationwide• Lone Star Medical Products, Inc

K C Pharmaceuticals Inc: Sterile Multi-Purpose Solution, NO RUB, for soft hydrophy...

Routine testing indicates product does not meet the expiration date in all cases.

FDAOct 4, 2004Nationwide• K C Pharmaceuticals Inc

Implant Innovations, Inc.: EP Healing Abutment- An abutment device is a premanufactu...

The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted.

FDAOct 4, 2004Nationwide• Implant Innovations, Inc.

Unknown Manufacturer: NOVAPLUS Electrosurgical Grounding Pads, Split with Cord ...

Improper wire placement from the patient plate to the ESU connector plug results in an intermittent displacement connection.

FDASep 30, 2004Nationwide

Fischer Imaging Corporation: VersaRad Generator

Some VersaRad Systems have a faulty weld that may result in oil leakage.

FDASep 30, 2004OR, VA• Fischer Imaging Corporation

Fujifilm Medical System USA, Inc.: Genital Protector Shield used with Fuji Computed Radiogra...

Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344 may detach from the mounting block and fall during use.

FDASep 30, 2004CO, CT, MD +5 more• Fujifilm Medical System USA, Inc.

Becton Dickinson & Co.: Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles...

Reagent for microbiological testing may cause inconsistent staining characteristics and subsequent misidentification of bacteria in patient samples.

FDASep 29, 2004Nationwide• Becton Dickinson & Co.

Abbott Laboratories: CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-0...

Elevated platelet background count results-some products may show a higher than expected platelet background count when used on the CELL-DYN 3200 System and report patient results that are unacceptable-out-of-range

FDASep 29, 2004GA, IL, PA +2 more• Abbott Laboratories

Siemens Medical Solutions USA, Inc: SOMATOM CT System Sensation Cardiac, Computed Tomography ...

Calcium Scoring feature on this devices is not closing properly after patient's exams.

FDASep 28, 2004Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: SOMATOM CT System Sensation 16, Computed Tomography X-Ray...

Calcium Scoring feature on this devices is not closing properly after patient's exams.

FDASep 28, 2004Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: SOMATOM CT System Sensation 10, Computed Tomography X-Ray...

Calcium Scoring feature on this devices is not closing properly after patient's exams.

FDASep 28, 2004Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: SOMATOM CT System Emotion Duo, X-Ray, Tomography, Compute...

Calcium Scoring feature on this devices is not closing properly after patient's exams.

FDASep 28, 2004Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: LEONARDO MM-WS, Computed Tomography X-Ray, Model Number 7...

Calcium Scoring feature on this devices is not closing properly after patient's exams.

FDASep 28, 2004Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: SOMATOM CT System Emotion 6, Computed Tomography X-Ray Sy...

Calcium Scoring feature on this devices is not closing properly after patient's exams.

FDASep 28, 2004Nationwide• Siemens Medical Solutions USA, Inc

Animas Corporation: IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 ...

Suspend mode not functioning properly

FDASep 28, 2004Nationwide• Animas Corporation

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