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Terminated

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. MRLCA000, REF/Catalog No. MRLCA000 -- medCOMP, 1499 Delp Drive, Harleysville, PA 19438 --- Description: The Celerity ECG Cable Accessory Pack is comprised of two sterile, single use components: a 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.

FDA Recall Z-1137-2017 · Posted 2017-02-03

Recalling FirmAngiodynamics Inc. (Navilyst Medical Inc.)
Recall StatusTerminated
Product CodeLJW
Date Initiated2016-09-07
Date Terminated2017-04-06

Reason for Recall

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.

Firm Action

On 9/7/2016, AngioDynamics, Inc. sent URGENT VOLUNTARY MEDICAL DEVICE RECALL Notifications (dated 9/7/2016) to 47 consignees via Federal Express. Consignees were instructed to segregate and return all affected devices to AngioDynamics and complete and return the Reply Verification Tracking Form, provided in the recall notification. Please call AngioDynamics Customer Service at 1-800-772-6446 Monday - Friday between 8:00 am and 7:00 Pm EST to obtain a replacement or credit for returned product.

Root Cause

Employee error

Distribution Pattern

AZ, CA, FL, GA, IL, IN, KS, MD, MO, MT, NC, NJ, NV, OH, OR, PA, TN, TX, WI

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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