Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transsept
FDA device recall Z-0085-2014 · posted 2013-11-01 · Terminated
Recall details
- Recalling firm
- Baylis Medical Corp *
- Reason for recall
- The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patients bloodstream.
- Action taken
- Baylis Medical sent an Urgent Device Recall Notification letter dated September 23, 2013, via overnight courier to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the response form provided and fax to 905-602-5671 ATTN: Quality Department to arrange for a free of charge replacement of the affected product. The form requires consignees to return the affected product. For questions contact Quality Assurance at 800-276-4416.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 370 devices
- Distribution
- Worldwide Distribution - USA Nationwide in the states of : NE, NH, NC, FL, PA, VA, MI, CA, AL, and TN and the countries of China, Canada, Saudi Arabia, and Italy.
- Date initiated
- 2013-09-23
- Date posted
- 2013-11-01
- Date terminated
- 2015-03-31
- Location
- Montreal, Canada
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TORFLEX TRANSSEPTAL GUIDING SHEATH (K102948) | Baylis Medical Co., Inc. | 2011-04-01 |