RECALLS AND FIELD CORRECTIONS 5

RECALLS AND FIELD CORRECTIONS 5 - ENFORCEMENT REPORT FOR...

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ENFORCEMENT REPORT FOR SEPTEMBER 8, 2010 Michael medlin RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I ___________________________________ PRODUCT AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system. Catheter is for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for improving myocardial perfusion. The devices are available in balloon diameters of 2.0-3.5 mm in 0.5 mm increments, and in scoring balloon lengths of 10 to 15 nm. Catheter length is 139 cm and is compatible with 0.014 inch guide wires and 6F guide catheters. The EX catheter is supplied sterile and intended for single use. Recall # Z-2218-2010 CODE Recall includes only EX Catheter products (all Part/REF Numbers 2034-XXYY) with lot numbers less than (<) F09060003 RECALLING FIRM/MANUFACTURER AngioScore Inc., Fremont, CA, by letter dated December 4, 2009. Firm initiated recall is ongoing. REASON Separations of the PTCA catheter shaft at the guide wire exit port have occurred during treatment of coronary artery stenosis. Fragments of the catheter may become lodged in coronary arteries, which resulting in serious patient outcome and require emergency coronary bypass surgery and medical intervention to remove the retained device fragments. VOLUME OF PRODUCT IN COMMERCE 3,870 units DISTRIBUTION Nationwide RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II ___________________________________ PRODUCT Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx Only. Usage: Temporary pacing of open hearts: used with External Pacing Generators (EPGs). Recall # Z- 2223-2010 CODE Lot number: 100701 RECALLING FIRM/MANUFACTURER Remington Medical Inc., Alpharetta, GA, by letter on/about May 19, 2010. Firm initiated recall is ongoing. REASON The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG. VOLUME OF PRODUCT IN COMMERCE 1488 units DISTRIBUTION AZ, CA, CO, CT, DE, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NM, NY, OH, OK, OR, PA, SC, TX, TN, TX, VA, WA, WI and Canada ___________________________________
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ENFORCEMENT REPORT FOR SEPTEMBER 8, 2010 Michael medlin PRODUCT medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit. Catalog #MRCTI66841. Recall # Z-2235-2010 CODE Lot #MAZL630, Exp. 04/2015 RECALLING FIRM/MANUFACTURER Medical Components, Inc dba MedComp, Harleysville, PA, by email on July 1, 2010. REASON Recalled product was packaged with the incorrect port and does not match the label. The kit is labeled as a 6.6F "Dignity" Low Profile CT Port. The kit contains a 6.6F "Pro-Fuse" Low Profile CT Port. VOLUME OF PRODUCT IN COMMERCE
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RECALLS AND FIELD CORRECTIONS 5 - ENFORCEMENT REPORT FOR...

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