Home / Recalls / Baxter Healthcare Corporation / Z-0939-2021

Z-0939-2021 Class II Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

FDA device recall Z-0939-2021 was initiated by Baxter Healthcare Corporation on December 28, 2020 and is designated Class II. Reason for recall: Potential for the battery to lose its ability to be recharged. The recall status is ongoing. Affected quantity: 109 units.

Recall Details

Product Type
Devices
Report Date
February 10, 2021
Initiation Date
December 28, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
109 units

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.

Reason for Recall

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

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

Code Information

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

Other recalls by Baxter Healthcare Corporation

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  • Z-2548-2026 Class I — Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog (May 21, 2026)
  • Z-2551-2026 Class I — Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Cat (May 21, 2026)
  • Z-2550-2026 Class I — Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catal (May 21, 2026)
  • Z-2549-2026 Class I — Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog (May 21, 2026)
  • Z-2262-2026 Class II — Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog N (April 22, 2026)
  • Z-2638-2026 Class II — Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjun (April 21, 2026)
  • Z-1637-2026 Class I — Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. (February 18, 2026)
  • Z-1573-2026 Class II — Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS (February 18, 2026)
  • Z-1368-2026 Class II — Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570 (January 13, 2026)

FDA data resources