GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures t
FDA device recall Z-2588-2014 · posted 2014-09-04 · Terminated
Recall details
- Recalling firm
- Galt Medical Corporation
- Reason for recall
- The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.
- Action taken
- Galt Medical sent an Urgent Medical Device Recall letters to all affected customers. The letter identified the affected product, reason for recall and actions to be taken. Customers were asked to identify and segregate the recalled lot (s) that is in their possession, complete and return the enclosed Recall Reply form, and return the recalled product to Galt Medical Corp. For questions contact your local sales representative or Recall Coordinator at 214-778-1306.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 11,155 units in total
- Distribution
- Worldwide Distribution - US (nationwide) Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece.
- Date initiated
- 2014-07-25
- Date posted
- 2014-09-04
- Date terminated
- 2016-02-26
- Location
- Garland, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT (K112398) | Galt Medical | 2012-04-12 |