FDASeptember 7, 2016device
Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No. 47-143 -- Legal Manufacturer: AngioDynamics, Inc. 10 Glens Falls Technical Park, Glens Falls, NY 12801; and (b) medCOMP UPN/Product No. MRLCA...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly manufactured. The affected product is not soldered per specification, and may result in the device not properly conducting the ECG signal.
What to do
FDA enforcement status: Terminated
Brands named
angiodynamics inc navilyst medical incangiodynamicsangiodynamics inc
Recall history
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