Boston Scientific Mach 1 peripheral Guide Catheter 6F, MP Multipurpose 90cm, .070 in (internal dia), Shaft lenght 90cm,
FDA device recall Z-1302-2008 · posted 2008-05-07 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.
- Action taken
- Consignees were sent a Boston Scientific Urgent Voluntary Medical Device Recall letter on 2/7/08. The letter included the customer steps for recall, a complete listing of all product batches being recalled, the Reply Verification Tracking Form(s) and a return shipping label.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 19
- Distribution
- Worldwide Distribution including USA states of PA, AZ, NY, KY, CA, WV, OH, WA, MI, TN, IN, IL, NJ, KY, FL, AR, FL, NC, CO, TX, WV, WI, OR, AL, MN and ND and countries of BE, FR, GB, DE, IE, IT, JP, AU
- Date initiated
- 2008-02-07
- Date posted
- 2008-05-07
- Date terminated
- 2008-11-03
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX (K020028) | Boston Scientific | 2002-01-22 |
| 6F MACH 1, MODEL 34356-XXX (K010874) | Boston Scientific Corp | 2001-06-21 |