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U.S. Department of Health and Human Services

Medical Device Recalls

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Product Description
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Recall
Class
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FDA Recall
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Recalling Firm
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TAPSYSTEM Model 2A, REF 8002A 3 07/15/2019 Cardiocommand Inc.
RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device 3 07/15/2019 Teleflex Medical
RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device 3 07/15/2019 Teleflex Medical
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retri... 3 07/03/2019 Roche Diagnostics Corporation
cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retri... 3 07/03/2019 Roche Diagnostics Corporation
Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead,... 3 06/26/2019 GE Healthcare, LLC
Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement EC... 3 06/26/2019 GE Healthcare, LLC
Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement EC... 3 06/26/2019 GE Healthcare, LLC
ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, ... 3 06/26/2019 GE Healthcare, LLC
ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 ... 3 06/26/2019 GE Healthcare, LLC

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