Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufac
FDA device recall Z-0031-2009 · posted 2008-10-02 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Boston Scientific is initiating a voluntary recall of the Platinum Plus" Guidewire (peripheral). BSC has received reports that product may be labeled as a 260 CM long guidewire when the actual packaged device is a 180 CM long guidewire and the product may be labeled as a 180 CM long guidewire when the actual packaged device is a 260 CM long guidewire. There is no expected potential for injury to
- Action taken
- A "Boston Scientific Urgent Voluntary Medical Device Recall or Correction - Immediate Action Required" letter dated 8/25/08 was sent to each affected account (To The Hospital Field Action Contact). The letter includes the customer steps for recall, a complete listing of all product batches/lots being recalled, the Reply Verification Tracking Form(s), and a return shipping label. Contact Boston Scientific Corporation at 1-763-494-1700 for assistance.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 35
- Distribution
- USA: CA FL GA IL IN LA MN MO NJ NV NY OH PA TN TX UT WA WI and WV OUS: France, Germany, Great Britain, Italy, and the Netherlands.
- Date initiated
- 2008-08-25
- Date posted
- 2008-10-02
- Date terminated
- 2011-12-10
- Location
- Maple Grove, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING (K945379) | Boston Scientific Corp | 1995-06-05 |
| PLATINUM PLUS GUIDEWIRE (K935997) | Boston Scientific Corp | 1994-06-17 |