Recall Z-1631-2016 ยท DPW Flowmeter, Blood, Cardiovascular
Baxter Healthcare Corp.
GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure
| Date | Apr 21, 2016 |
| Status | Terminated |
| Reason | Instructions for use booklet may puncture the outer Tyvek lid. |
| Root cause | Package design/selection |
| Action | Baxter sent an Urgent Product Recall letter dated April 21, 2016 to customer. The letter identified the affected product, problem and actions to be taken. The letters requested that direct consignees contact Synovis MCA to arrange for return and credit. Companies that further distributed the product were asked to notify other facilities or departments. For questions contact Synovis MCA at 800-510-3318 or 205-941-0111. |
| Quantity | 118 units |
| Distribution | Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143589 | GEM Flow COUPLER Device and System Synovis Life Technologies, Inc., Jan 16, 2015 |