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U.S. Department of Health and Human Services

Class 1 Device Recall Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port

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  Class 1 Device Recall Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port see related information
Date Initiated by Firm December 17, 2009
Date Posted February 02, 2010
Recall Status1 Terminated 3 on November 01, 2010
Recall Number Z-0661-2010
Recall Event ID 54193
510(K)Number K003731  
Product Classification vascular introducer - Product Code DYB
Product Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port, for the introduction of various types of pacing or defibrillator leads and catheters. The product is shipped 5 per carton. Product is distributed by Pressure Products. Catalog numbers: CSG/MSP-00-09, CSG/90-09, CSG-KR-90-09, CSG/WORLEY-1-09, CSG-WORLEY-Bcor-1-09, CSG/WORLEY/L/Bcor-1-09, CSG/WORLEY-2-09, CSG/WORLEY/Bcor-2-09, CSGMSP0009M, CSGWORLEY109M, CSGWORL19M, CSGWORBC19M, CSGWORLBC19M, CSGWORBC29M, CSG/Worley/BCor-1-07, CSG/Worley/BCor-2-07, CSG/WORLEY/BCOR-M-09, and CSG/Worley/R-1-09.
Code Information Catalog numbers: CSG/MSP-00-09, CSG/90-09, CSG-KR-90-09, CSG/WORLEY-1-09, CSG-WORLEY-Bcor-1-09, CSG/WORLEY/L/Bcor-1-09, CSG/WORLEY-2-09, CSG/WORLEY/Bcor-2-09, CSGMSP0009M, CSGWORLEY109M, CSGWORL19M, CSGWORBC19M, CSGWORLBC19M, CSGWORBC29M, CSG/Worley/BCor-1-07, CSG/Worley/BCor-2-07, CSG/WORLEY/BCOR-M-09, and CSG/Worley/R-1-09. Lot numbers: S16716, S17215, S17216, S17248, S17349, S17447, S17448, S17449, S17478, S17596, S17640, S17675, S17789, S17790, S17795, S17864, S18000, S18004, S18290, S18291, S18336, S18337, S18352, S18529, S18535, S18593, S18670, S18725, S18736, S18744, S18745, S18861, S18862, S18952, S18962, S18974, S19051, S19060, S19135, S19153, S19161, S19173, S19174, S19175, S19196, S19262, S19264, S19290, S19291, S19292, S19409, S19428, S19450, S19564, S19742, S19743, S19756, S19757, S19906, S19959, S19961, S19966, S19991, S20007, S20019, S20101, S20154, S20170, S20297, S20298, S20331, S20491, S20494, S20505, S20704, S20713, S20848, S21002, S21071, S21115, S21128, S21236, S21557, S21650, S21651, S21652, S21695, S22085, S22160, S22216, S22228, S22229, S22244, S22282, S22302, S22367, S22368, S22371, S22396, S22397, S22491, S22675, S22676, S22746, S23020, S23021, S23022, S23052, S23092, S23103, S23111, S23112, S23225, S23384, S23387, S23388, S23402, S23403, S23492, S23507, S23508, S23543, S23618, S23795, S23926, S23927, S23956, S24026, S24027, S24101, S24174, S24175, S24341, S24353, S24354, S24355, S24619, S24620, S24772, S24800, S24852, S24906, S24907, S24931, S24951, S24956, S24958, S24978, S25050, S25051, S25052, S25082, S25097, S25121, S25140, S25141, S25142, S25239, S25241, S25323, S25324, S25353, S25404, S25433, S25469, S25486, S25487, S25494, S25497, S25590, S25590X1, S25594, S25720, S25721, S25806, S25807, S25896, S26039, S26039X1, S26040, S26040X1, S26088, S26095, S26183, S26183X1, S26345, S26554X1, S26570X1, S26576, S26635X1, S26636X1, S26637X1, S26752, S26754, S26833, S26834, S26912, S27030, S23031, S27032, S27056, S27057, S27186, S27242, S27321, S27504, S27610, S27611, S27617, S27646, S27670, S27876, S27895, S27913, S27914, S27924, S27952, S28054, S28214, S28215, S28232, S28272, S28273, S28283, S28326, S28360, S28391, S28460, S28485, S28564, S28576, S28731, S28808, S28894, S28939, S29270, S29492, S29669, S29736, S29766, S29767, S29813, S29823, S29879, S30059, S20357, S30060, S30258, S99009X1, S99010X1, S99011X1, and S99052X1.
Recalling Firm/
Manufacturer		 Thomas Medical Products Inc
65 Great Valley Pkwy
Malvern PA 19355-1302
For Additional Information Contact Tim Stoudt
610-296-3000
Manufacturer Reason
for Recall		 Radiopaque sheath tip may fracture
FDA Determined
Cause 2		 Component design/selection
Action GE Healthcare Thomas Medical Products firm issued an Urgent Medical Device Correction email on 12/23/09 to the distributor to discontinue distribution and return any affected products. The distributor was instructed to conduct a sub recall regarding the issue. Press issued 1/29/2010.
Quantity in Commerce 60,982 units
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = THOMAS MEDICAL PRODUCTS, INC.
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