Baxter Recalls GEM FlowCOUPLER Due to Packaging Lid Puncture Risk
Baxter Healthcare is recalling 288 units of GEM FlowCOUPLER devices because the instructions for use booklet may puncture the outer Tyvek lid.
- Product
- GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-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…
- Category
- Medical Device
- Distribution
- Distributed nationwide