Recall Z-0939-2021 ยท MVR Device, Anastomotic, Microvascular
Baxter Healthcare Corporation
FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.
| Date | Dec 28, 2020 |
| Status | Open, Classified |
| Reason | Potential for the battery to lose its ability to be recharged. |
| Root cause | Software design |
| Action | Written notification letter titled, "Urgent Medical Device Recall" was sent to all consignees on 12/28/2020 via first class mail. The letter instructs the consignee to locate all affected devices at their facility; contact Synovis MCA to arrange for product return for the firmware upgrade, power button update, and battery replacement, if applicable; complete the enclosed Baxter customer reply form and return it to Baxter by e-mailing it to fca@baxter.com, even if the consignees does not have any inventory; and if the consignee distributes this product to other facilities or departments within |
| Quantity | 109 units |
| Distribution | Distributed nationwide to AZ, FL, OH, NY, GA, VA, MA, WI, MO, MT, WV, IL, NC, NJ, AR, CA, CO, CT, IA, ID, IN, KS, LA, MD, MI, MN, MS, NE, NH, NM, NV, OK, OR, PA, RI, WY, WA, VT, TX, TN, SC, SD |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191252 | Gem FlowCoupler System Baxter/ Synovis Micro Companies Alliance, Inc., Jul 9, 2019 |