Mach 1 6F Kimny Guide Catheter. Catalog No. 34356-583. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for on
FDA device recall Z-0432-06 · posted 2006-01-24 · Terminated
Recall details
- Recalling firm
- Boston Scientific Scimed
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 10 devices
- Distribution
- Within the US to GA, MS, NC ,TN. OUS to include: Canada, Hong Kong, Italy, Netherlands, Saudi Arabia, United Kingdom
- Date initiated
- 2004-05-24
- Date posted
- 2006-01-24
- Date terminated
- 2007-01-23
- Location
- Maple Grove, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 6F MACH 1, MODEL 34356-XXX (K010874) | Boston Scientific Corp | 2001-06-21 |