Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only.
FDA Recall Z-1950-2011 · Posted 2011-04-12
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Recalling FirmHeart Sync, Inc
Recall StatusTerminated
Product CodeMLN
Date Initiated2008-12-05
Date Terminated2011-04-13
Product Quantity2100 (210 cases of 10 each)
Reason for Recall
The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration.
Firm Action
The firm sent a recall notice to their distributors on 12/3/2008 asking them to quarantine product and return it to HeartSync. The letter stated that customers' current inventory would be exchanged for new product. Customers were to call 1-800-828-4681 to provide the necessary information.
Root Cause
Equipment maintenance
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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