Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway, Montreal, QC, Canada H4T1A1,
FDA device recall Z-0816-2010 · posted 2010-03-10 · Terminated
Recall details
- Recalling firm
- Baylis Medical Corp *
- Reason for recall
- Radiopaque soft tip may fracture.
- Action taken
- Baylis Medical Issued an "Urgent Medical Device Correction" letter via overnight courier beginning February 8, 2010. Consignees were instructed to segregate and return all affected product to the firm. For further information, contact Baylis Medical Regulatory Scientific Affairs at 1-905-602-4875 Extension 252.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 1,085 units (508 in US, 577 Foreign)
- Distribution
- Worldwide Distribution -- United States, Canada, Chile, China, Colombia, Denmark, Egypt, France, Germany, Hong Kong, Italy, Mexico, Netherlands, New Zealand, Portugal, Qatar, Russia, Singapore, South
- Date initiated
- 2010-02-08
- Date posted
- 2010-03-10
- Date terminated
- 2010-09-13
- Location
- Montreal, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TORFLEX TRANSSEPTAL GUIDING SHEATH (K013919) | Baylis Medical Co., Inc. | 2002-02-22 |