Mach 1 6F JR 3.5 Guide Catheter. Catalog No. 34356-685. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacture: Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311
- Company
- Boston Scientific Scimed
- Recall Initiated
- May 24, 2004
- Posted
- January 24, 2006
- Terminated
- January 23, 2007
- Recall Number
- Z-0433-06
- Quantity
- 10 devices
- Firm Location
- Maple Grove, MN
Reason for Recall
Some Mach 1 6F Coronary Guide Catheter could be mislabeled in that a few units labeled as Mach 1 6F Kimny Curve style, could contain a Mach 1 6F JR 3.5 curve style and a few units labeled as Mach 1 6F JR 3.5 curve style, could contain a Mach 1 6F Kimny curve style.
Distribution
Within the US to GA, MS, NC ,TN. OUS to include: Canada, Hong Kong, Italy, Netherlands, Saudi Arabia, United Kingdom
Lot / Code Info
Product UPN H749343566850, Lot # 6287583
Root Cause
Other
Action Taken
A Recall Notice, dated 05/28/05, was sent to Risk Managers. The notice informed them of the issue and instructed them to discontinue use and segregate affected units. A Tracking/verification Form is requested to be returned. Arrangements will be made for returning affected product.
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