Covidien LLC — Class II: Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
Covidien LLC has issued a Class II recall for the Mon-a-Therm general purpose temperature probe (size 9 Fr, REF 90050) because the devices lack required FDA clearance.
This affects Covidien LLC, clinical facilities utilizing Mon-a-Therm temperature probes, and regulatory/QA departments responsible for ensuring valid marketing authorizations for monitoring equipment.
The lack of FDA clearance indicates a fundamental regulatory deficiency, suggesting that the product was distributed without the necessary pre-market review for safety and effectiveness. This situation typically necessitates immediate cessation of distribution and may signal broader gaps in the firm's regulatory controls regarding product lifecycle management or device classification.
Regulatory teams should verify that all temperature probes currently in distribution have active 510(k) clearances. QA should pull the impacted Mon-a-Therm (REF 90050) inventory and evaluate the necessity of a retrospective review of the design history file for regulatory gaps.
Class II. Reason: Temperature probe devices lack FDA clearance.. Product: Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050. Firm: Covidien LLC (Boulder CO United States). Status: Ongoing.
Open in openFDA / FDA.gov