—#185040

Product

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.

FDA product code: MVR — Device, Anastomotic, Microvascular
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K191252
Affected lot / code info: UDI: 00844735006148; Product Code: 5156-00000-011; Serial Numbers: 135306000279, 135306000280, 135306000281, 135306000282, 135306000283, 135306000284, 135306000286, 135306000287, 135306000288, 135306000289, 135306000290, 135306000291, 135306000292, 135306000293, 135306000294, 135306000295, 135306000298, 135306000299, 135306000300, 135306000301, 135306000303, 135306000304, 135306000305, 135591000306, 135591000307, 136959000309, 136959000310, 136959000311, 136959000312, 136959000313, 136959000314, 136959000315, 136959000316, 136959000317, 136959000318, 136959000319, 136959000320, 136959000321, 136959000322, 136959000323, 136959000324, 136959000325, 136959000326, 136959000327, 136959000328, 136959000329, 136959000330, 136959000331, 136959000332, 136959000333, 136959000334, 136959000335, 136959000336, 136959000337, 136959000338, 136959000339, 136959000340, 136959000341, 136959000342, 136959000344, 136959000345, 136959000346, 136959000347, 136959000348, 136959000349, 136959000350, 136959000351, 136959000352, 136959000353, 136959000354, 136959000355, 136959000357, 136959000358, 136959000359, 136959000360, 136959000361, 136959000362, 136959000364, 136959000365, 136959000366, 137645000392, 137645000393, 137645000394, 137645000395, 137645000396, 137645000397, 137645000399, 137645000400, 137645000401, 139608000552, 139608000555, 139608000571, 139609000583, 139609000589, 139609000596, 139609000597, 139609000598, 139609000599, 139609000600, 139609000601, 139609000602, 139609000603, 139609000604, 139609000605, 139609000606, 139609000607, 139609000608, 139609000609, 139609000610

Why it was recalled

Potential for the battery to lose its ability to be recharged.

Root cause (FDA determination)

Software design

Action the firm took

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 their institution, to please forward a copy of this communication to them.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2020-12-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185040. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.