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Medical Device Recalls
Class 2 Recall
Medtronic
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Date Recall Initiated |
April 05, 2006
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Date Posted |
June 01, 2006
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Recall Number |
Z-1075-06
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Product |
6F ZUMA SR4.0
CATHETER ZM6SR40 ZM 6F 100CM SR4.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system.
Product Code: ZM6SR40
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Code Information |
Lot Numbers:
0000000770
0000002134
0000028207
0000043814
0000090410
0000103759
0000125699
0000137834
0000151268
0000164481
127482
128283
128616
128988
130040
130595
132042
134208
135297
136396
138223
139414
141461
145170
152777
154356
155657
160606
166965
175986
186044
188373
204387
208088
217819
223496
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Recalling Firm/ Manufacturer |
Medtronic, Inc.
35 -37A Cherry Hill Dr
Danvers
, Massachusetts
01923-2565
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For Addition Information Contact |
Fred Boucher
978-739-3116
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Reason For Recall |
Potential for non-sterility due to loss of package integrity
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Action |
Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form. .
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Quantity in Commerce |
577 units
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Distribution |
Nationwide
Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.
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