FLOW COUPLER Monitor Flow Coupler devices are sold in 5 recall
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.
Why was FLOW COUPLER Monitor Flow Coupler devices are sold in 5 recalled?
Potential for the battery to lose its ability to be recharged.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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.
- Recalling firm
- Baxter Healthcare Corporation
- 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
- Recall date
- February 10, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)