GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-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 the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
This recall has been terminated (originally issued April 21, 2016).
- Company
- Baxter Healthcare Corp.
- Recall Initiated
- April 21, 2016
- Terminated
- November 22, 2016
- Recall Number
- Z-1629-2016
- Quantity
- 707 units
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Instructions for use booklet may puncture the outer Tyvek lid.
Distribution
Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada
Lot / Code Info
SP15H05-1067841 thru SP15L02-1102423
Root Cause
Package design/selection
Action Taken
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.
More recalls by Baxter Healthcare Corp.
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634
Product Usage:...
Nov 8, 2016
V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -...
Sep 28, 2016
Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Co...
Sep 28, 2016