Boston Scientific, Fort Guide Wire, Floppy, 300cm x 2 cm REF 34949-04, for use in intravascular interventional procedure
FDA device recall Z-1487-2009 · posted 2009-06-24 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Product packaged incorrectly. One batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot of wires, which should not contain radiopaque marker bands, has the marker bands. Since the marker bands issue would not be visually apparent to the physician there is a potential for prolongation or delay of the procedure in order to exchange the
- Action taken
- Consignees were sent a "Boston Scientific Urgent Medical Device Recall" letter dated may 19, 2009. The letter was addressed to "Dear Risk Manger/ Field Action Contact". The letter described the problem, customer steps for recall and listing of product batches / lots. The letter requested consignees to return the Reply Verification Tracking Form.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- Total of 4 boxes (5 units /box).
- Distribution
- USA distribution: AR, MO, CA, FL, and NV.
- Date initiated
- 2009-05-12
- Date posted
- 2009-06-24
- Date terminated
- 2011-12-11
- Location
- Maple Grove, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STREERABLE PTCA GUIDEWIRE (K011968) | Lake Region Mfg., Inc. | 2001-07-25 |