Reported Feb 15, 2017 · Terminated
Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics…
Angiodynamics Inc. (Navilyst Medical Inc.)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Angiodynamics Inc. (Navilyst Medical Inc.) · 10 Glens Falls Tech Park · Glens Falls, NY · 12801-3864
Is this the product you have?
- Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY -
- distributed under the following labels
(a) angiodynamics UPN/Product No. H787471431REF/Catalog No. 47-143 --
- Legal Manufacturer
AngioDynamicsInc. 10 Glens Falls Technical ParkGlens FallsNY 12801and (b) medCOMP UPN/Product No. MRLCA000REF/Catalog No. MRLCA000 -- medCOMP1499 Delp DriveHarleysville
- PA 19438 --- DescriptionThe Celerity ECG Cable Accessory Pack is comprised of two sterile
- single use componentsa cable cover and an ECG clip cable (alligator clip). The cable cover is used to sleeve the remote control cable component of the Celerity System so that the user can remotely control the monitor within the sterile field. The stereo jack end of the remote control cable pierces the sterile cable cover and interfaces with the stereo jack connector end of the ECG clip cable. The alligator clip side of the ECG clip cable is clamped to the stylet or guidewire to provide the intravascular cavity ECG reading
- Lot codes and dates
- AngioDynamics
- UPN H787471431 Batch/Lot Numbers
5015180MBVR240DMBVT150RMBVT210DMBVT220DMBVT240DMBVT250DMBVT680DMBVT700DMBVX090DmedCOMP UPN MRLCA000Batch/Lot Number MBVT240
- Amount recalled
- N/A
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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