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FLOW COUPLER Monitor recallZ-0939-2021 · Baxter Healthcare Corporation · initiated Dec 28, 2020

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Software design

What the company is doing

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 [email protected], 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.

Recall details

Recall number
Z-0939-2021
Status
Open, Classified
Initiated by the company
Dec 28, 2020
Recalling firm
Baxter Healthcare Corporation
Quantity
109 units
Product code
MVR
FDA submissions
K191252
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

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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