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Showing 17101–17120 of 22396 results

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BD Biosciences: BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Comp...

Values might not update in statistics views after certain functions are performed in a worksheet.

FDADec 21, 2007Nationwide• BD Biosciences

OEC Medical Systems, Inc: Vascular Drape, Surgical drape and drape accessories; Ref...

No Premarket Notification: Product does not have FDA 510(k) approval for use.

FDADec 20, 2007Nationwide• OEC Medical Systems, Inc

Seradyn, Inc.: Seradyn QMS Vancomycin reagents, Part Number: 0373589. Se...

False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.

FDADec 20, 2007CA, NY• Seradyn, Inc.

Myelotec, Inc.: Myelotec Steerable Video Guided Catheter, 2.7mm, label in...

Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation.

FDADec 19, 2007AL, CA, CT +11 more• Myelotec, Inc.

Arjo, Inc.: BHM Medical Scales, 800 lb. scale weight limit; Part Numb...

Unintended Hanger Bar Detachment: The locknut on the scales may loosen during use and allow the hanger bar assembly of the patient lift to detach and fall.

FDADec 19, 2007Nationwide• Arjo, Inc.

Abbott Laboratories: White Blood Cell (WBC) Reagent-Part A used with the CELL-...

Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.

FDADec 19, 2007AL, AK, AZ +35 more• Abbott Laboratories

Arjo, Inc.: BHM Medical Scales, 1000 lb. scales weight limit; Part Nu...

Unintended Hanger Bar Detachment: The locknut on the scales may loosen during use and allow the hanger bar assembly of the patient lift to detach and fall.

FDADec 19, 2007Nationwide• Arjo, Inc.

Abbott Spine: Comfort T-Handle Hudson Connector with Impactor Cap; Part...

Dislodged Collar Spring; The collar spring binding on the shaft of generic handle used with multiple surgical instruments has the potential to release the device's internal bearings during use.

FDADec 19, 2007AZ, AR, CA +20 more• Abbott Spine

Zimmer Orthopaedic Surgical Products: Pulsavac, Plus Wound Debridement System, Component Kit, C...

Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.

FDADec 18, 2007Nationwide• Zimmer Orthopaedic Surgical Products

Lifescan Inc: LifeScan OneTouch Data Management Software Version 1.0, P...

Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily.

FDADec 18, 2007Nationwide• Lifescan Inc

Zimmer Orthopaedic Surgical Products: Pulsavac Plus AC Fan Spray Kit, Catalog #00-5150-476-01, ...

Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.

FDADec 18, 2007Nationwide• Zimmer Orthopaedic Surgical Products

GE Healthcare: GE Healthcare Precision RXi version e Remote X-Ray Imagin...

GE Healthcare Precision RXi tilt joystick became stuck in the Trendelenburg direction causing the patient to slide off the table. Also recall conducted to investigate the possibility of accidentally activation of the remote console joystick where a fatal accident occurred on a non-GE Remote R&F System. .

FDADec 18, 2007AK, CA, CO +18 more• GE Healthcare

Zimmer Orthopaedic Surgical Products: Pulsavac Plus AC Hip Kit, Catalog #00-5150-486-01, 1 kit/...

Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.

FDADec 18, 2007Nationwide• Zimmer Orthopaedic Surgical Products

Zimmer Orthopaedic Surgical Products: Pulsavac Fan Spray Kit ,Catalog #00-5150-475-01; 1kit/pa...

Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.

FDADec 18, 2007Nationwide• Zimmer Orthopaedic Surgical Products

Zimmer Orthopaedic Surgical Products: Pulsavac Plus Low Pressure Fan Spray Kit, Catalog #00-515...

Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.

FDADec 18, 2007Nationwide• Zimmer Orthopaedic Surgical Products

Zimmer Orthopaedic Surgical Products: Pulsavac Plus AC Component Kit, Catalog #00-5150-426-01, ...

Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.

FDADec 18, 2007Nationwide• Zimmer Orthopaedic Surgical Products

GE Healthcare: GE Healthcare Precision RXi 23A/ 32A Remote X-Ray Imaging...

GE Healthcare Precision RXi tilt joystick became stuck in the Trendelenburg direction causing the patient to slide off the table. Also recall conducted to investigate the possibility of accidentally activation of the remote console joystick where a fatal accident occurred on a non-GE Remote R&F System. .

FDADec 18, 2007AK, CA, CO +18 more• GE Healthcare

Zimmer Orthopaedic Surgical Products: Pulsavac Hip Kit ,Catalog #00-5150-482-01, 1kit/package, ...

Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.

FDADec 18, 2007Nationwide• Zimmer Orthopaedic Surgical Products

GE Healthcare: GE Healthcare Precision RXi Digital Remote X-Ray Imaging ...

GE Healthcare Precision RXi tilt joystick became stuck in the Trendelenburg direction causing the patient to slide off the table. Also recall conducted to investigate the possibility of accidentally activation of the remote console joystick where a fatal accident occurred on a non-GE Remote R&F System. .

FDADec 18, 2007AK, CA, CO +18 more• GE Healthcare

Lumenis, Inc.: Boston Scientific SlimLine 200 Micron Holmium Fiber Deliv...

Incorrect Label: The Units outer pouch is labeled 200 micro fiber however, the inner pouch's label affixed to the product indicated that it is a 365 micron fiber. The micron fiber contained in the inner pouch is 200 micro fiber. The inner product is mislabeled with the wrong size.

FDADec 18, 2007MA• Lumenis, Inc.

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