Recall Z-2329-2016 ยท MGB Device, Hemostasis, Vascular
AccessClosure, Inc., A Cardinal Health Company
6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 6F or 7F procedural sheath. The 6F/7F MynxGrip Vascular
| Date | Aug 3, 2016 (initiated Jul 13, 2016) |
| Status | Terminated |
| Reason | A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations. |
| Root cause | Process control |
| Action | Cardinal Health sent an Urgent Medical Device letters dated July 15, 2016 to affected customers. The letters provided the reason for recall and the exact lot number and quantity shipped to each location. Customers were instructed to quarantined affected products and complete and return the Field Action response form indicating the number of devices that will be returned. Instructions for returning the devices are included with an RMA number and Fed Ex airbill. Questions should be directed to Customer Advocacy at 408-610-6570 between 9 am and 5 pm PST. |
| Quantity | 55 units |
| Distribution | US in the states of CA, and MS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.