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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 5 of 5 Results
510(K) Number: K132727
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Product Description
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Recall
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FDA Recall
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GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage... 2 05/10/2016 FEI # 1417572
Baxter Healthcare Corp.
GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usa... 2 05/10/2016 FEI # 1417572
Baxter Healthcare Corp.
GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage... 2 05/10/2016 FEI # 1417572
Baxter Healthcare Corp.
GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage:... 2 05/10/2016 FEI # 1417572
Baxter Healthcare Corp.
FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-... 2 07/29/2014 FEI # 3000121413
Baxter Healthcare Corporation
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