AngioDynamics Recalls Celerity ECG Cable Accessory Packs Due to Soldering Defect
AngioDynamics is recalling Celerity ECG Cable Accessory Packs because the ECG clip cable may not be soldered correctly, potentially preventing the device from conducting ECG signals.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (failure to conduct ECG signal) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
AngioDynamics Inc. (Navilyst Medical Inc.) is recalling the Celerity ECG Cable Accessory Pack, a sterile, single-use medical device. The product is distributed under the AngioDynamics and medCOMP labels. The recall is due to a manufacturing defect where the ECG Clip Cable may not be soldered per specification. This defect may result in the device not properly conducting the ECG signal.
The affected product is distributed in Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Missouri, Montana, North Carolina, New Jersey, Nevada, Ohio, Oregon, Pennsylvania, Tennessee, Texas, and Wisconsin. Specific batch and lot numbers are identified in the recall documentation, including AngioDynamics UPN H787471431 and medCOMP UPN MRLCA000.
Healthcare providers and facilities should stop using the affected Celerity ECG Cable Accessory Packs and contact the recalling firm for instructions on return or replacement. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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/
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- AngioDynamics UPN H787471431 Batch/Lot Numbers: 5015180
- MBVR240D
- MBVT150R
- MBVT210D
- MBVT220D
- MBVT240D
- MBVT250D
- MBVT680D
- MBVT700D
- MBVX090D
- medCOMP UPN MRLCA000
- Batch/Lot Number MBVT240.
Distribution
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