RECALLS AND FIELD CORRECTIONS 3

RECALLS AND FIELD CORRECTIONS 3 - Michael medlin REPORT FOR...

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Michael medlin REPORT FOR AUGUST 25, 2010 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II ______________________________________ PRODUCT 19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm Agfa's Computed Radiography Systems with NX2.X software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Recall # Z-2100-2010 CODE Lot: LU8QJ000 RECALLING FIRM/MANUFACTURER Recalling Firm: AGFA Corp., Greenville, SC, by letter dated June 30, 2010. Manufacturer: Agfa Healthcare Corp., Carlstadt, NJ. Firm initiated recall is ongoing. REASON Monitor fell from the mounting bracket used to support the monitor VOLUME OF PRODUCT IN COMMERCE 805 units DISTRIBUTION Nationwide and Canada ______________________________________ PRODUCT 1) Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35180, 180cm, Sterile EO. Intended to facilitate the placement of devices during diagnostic and interventional procedures. Recall # Z-2101-2010; 2) Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In Ireland, CAT No: LWSTFA35180, 180cm, Sterile EO. Intended to facilitate the placement of devices during diagnostic and interventional procedures. Recall # Z-2102-2010; 3) Merit Laureate Hydrophylic Guide Wire, Straight, Made In Ireland, CAT No: LWSTFS35180, 180cm, Sterile EO. Intended to facilitate the placement of devices during diagnostic and interventional procedures. Recall # Z-2103-2010; 4) Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35260EX, 260cm, Sterile EO. Intended to facilitate the placement of devices during diagnostic and interventional procedures. Recall # Z-2104-2010; 5) Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In Ireland, CAT No: LWSTFA35260EX, 260cm, Sterile EO. Intended to facilitate the placement of devices during diagnostic and interventional procedures. Recall # Z-2105-2010 6) Merit Laureate Hydrophylic Guide Wire, Straight Stiff Shaft, Made in Ireland, CAT No: LWSTFS35260EX, 260cm, Sterile EO. Intended to facilitate the placement of devices during diagnostic and interventional procedures. Recall # Z-2106-2010 CODE 1) Lot Number K131823; 2) Lot Number K131824; 3) Lot Number K131832;
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Michael medlin REPORT FOR AUGUST 25, 2010 4) Lot Number K130761 (3 year expiry), P116003 (1 year expiry); 5) Lot Number K131835; 6) Lot Number K131837 RECALLING FIRM/MANUFACTURER Recalling Firm: Merit Medical Systems, Inc., South Jordan, UT, by e-mail on June 28, 2010. Manufacturer: Merit Medical Ireland Ltd., Galway, Ireland. Firm initiated recall is complete. REASON Guidewires have decreased lubricity at the proximal end, inhibiting proper operation. VOLUME OF PRODUCT IN COMMERCE
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This note was uploaded on 07/10/2011 for the course ECON 101 taught by Professor Tuner during the Spring '11 term at Solano Community College.

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RECALLS AND FIELD CORRECTIONS 3 - Michael medlin REPORT FOR...

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