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Showing 19741–19760 of 22584 results

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Sunrise Medical CCG, Inc.: Joerns Ultra Care 770 Model AC Powered Beds with model nu...

The control box used in the actuator systems appears to have a potential to become stuck in one position resulting a non-functioning bed.

FDAJan 1, 2006Nationwide• Sunrise Medical CCG, Inc.

Boston Scientific Corp: Chilli II Cooled Ablation Cathether, Model M00490310

Product is mislabeled with the incorrect catheter curve description.

FDADec 30, 2005IN• Boston Scientific Corp

Unknown Manufacturer: IntraStent DoubleStrut LD - Balloon Expandable Biliary St...

IntraStent product S15-36 (P/N 90-1341-02) lot 494428 was labeled as IntraStent product S15-26 (P/N 90-1341-001)

FDADec 29, 2005AR, GA, IN +3 more

Draeger Medical, Inc.: Babylog 8000 plus with software version 5.n. Neonatal Res...

Failure to generate an alarm when an unintended disconnection occurrs

FDADec 28, 2005Nationwide• Draeger Medical, Inc.

BioHorizons Implant Systems Inc One Perimeter Park South: BioHorizons Maximus 3.0 surgical kit, also marketed as Bi...

Dental implants were distributed which lacked the proper instruments for implantation.

FDADec 28, 2005Nationwide• BioHorizons Implant Systems Inc One Perimeter Park South

Acumed LLC: 3.5mm X 32.5mm Cortical Screw used with the Polarus Humer...

Package of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 22.5mm cortical screw.

FDADec 27, 2005AZ, CA, FL +15 more• Acumed LLC

Philips Medical Systems (Cleveland) Inc: Brilliance CT System 6/10/16/16P/40 configuration. No pa...

The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle.

FDADec 27, 2005AZ, CO, GA +16 more• Philips Medical Systems (Cleveland) Inc

Respironics, Inc.: NeoPAP Neonatal CPAP/Humidification System (Ventilator, C...

Vapotherm humidification cartridges were found to contain microbial (Ralstonia spp.) cultures. This device uses cartridges from the same supplier.

FDADec 27, 2005GA, IN, IA +7 more• Respironics, Inc.

Philips Medical Systems (Cleveland) Inc: Brilliance CT System 6/10/16/16P/40 configuration. No pa...

The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle.

Class IIModerate

FDADec 27, 2005AZ, CO, GA +16 more• Philips Medical Systems (Cleveland) Inc

Blackstone Medical Inc.: ICON Modular Spinal Fixation System used with the: ICON I...

Pedicle Screw may disengage in post op period requiring intervention

FDADec 23, 2005AL, CA, CO +4 more• Blackstone Medical Inc.

Abbott Laboratories Diagnostic Div: Clinical Chemistry Multiconstituent Calibrator--- List nu...

The two Multiconstituent Calibrator (MCC) lot numbers 19906M200 and 20879M100 failed to meet product performance expectations throughout the labeled expiration period, as a result of the shortened expiration dating, two lots are now expired. The expiration date for Lot number 26674M100 will be revised from 2006-07-31 to 2006-01-31.

FDADec 23, 2005Nationwide• Abbott Laboratories Diagnostic Div

Medtronic Sofamor Danek Instrument Manufacturing: Holt Probe Round Straight

Depth indicators are incorrectly labeled (etched) on a measurement instrument.

FDADec 22, 2005Nationwide• Medtronic Sofamor Danek Instrument Manufacturing

Davol, Inc., Sub. C. R. Bard, Inc.: Bard Composix Kugel Oval, 6.3'' x 12.3'' for hernia rep...

Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula. (Extension of recall Z-0524/0526-06)

FDADec 22, 2005Nationwide• Davol, Inc., Sub. C. R. Bard, Inc.

Davol, Inc., Sub. C. R. Bard, Inc.: Bard Composix Kugel Large Circle, 4.5'' for hernia repai...

Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula. (Extension of recall Z-0524/0526-06)

FDADec 22, 2005Nationwide• Davol, Inc., Sub. C. R. Bard, Inc.

Davol, Inc., Sub. C. R. Bard, Inc.: Bard Composix Kugel Large Oval, 5.4'' x 7'' for hernia r...

Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula. (Extension of recall Z-0524/0526-06)

FDADec 22, 2005Nationwide• Davol, Inc., Sub. C. R. Bard, Inc.

Teco Diagnostics: Uritek TC-101Urine Analyzer, catalog number TC-101

When reading the Nitrite parameter on the Teco Diagnostics URS-10 strips, some positive nitrite samples may be read by the machine as negative.

FDADec 22, 2005Nationwide• Teco Diagnostics

Davol, Inc., Sub. C. R. Bard, Inc.: Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8...

Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula

FDADec 22, 2005Nationwide• Davol, Inc., Sub. C. R. Bard, Inc.

Abbott Laboratories MPG: ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each...

There has been an increase in customer complaints observed for failure to calibrate or inability to generate patient result errors.

FDADec 21, 2005Nationwide• Abbott Laboratories MPG

Praxair Distribution Inc.: Praxair Grab ''n Go Vantage unit, model PRX-9495.

The units may experience a delay in oxygen flow upon initial actuation.

FDADec 21, 2005CA, IL, IN +5 more• Praxair Distribution Inc.

Baxter Healthcare Renal Div: Baxter BM11 Blood Monitor Pump hemodialysis machine; Baxt...

Advisory to alert users to assure that the hemofilter of the blood line is in the horizontal position to avoid kinking of the bloodline tubing to avoid hemolysis, and to show the compatible blood tubing sets to be used with the BM11/BM11A Blood Monitor Pump and BM25 System ultrafiltration hemodialysis system.

FDADec 21, 2005Nationwide• Baxter Healthcare Renal Div

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