Recall Z-2589-2014 ยท DYB Introducer, Catheter
Galt Medical Corporation
GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
| Date | Sep 4, 2014 (initiated Jul 25, 2014) |
| Status | Terminated |
| Reason | The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 11,155 units in total |
| Distribution | Worldwide Distribution - US (nationwide) Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112398 | TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT Galt Medical, Apr 12, 2012 |