Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V

FDA Recall Z-0037-05 · Posted 2004-10-22

Recall StatusTerminated
Product CodeJOS
Date Initiated2004-09-30
Date Terminated2005-11-14
Product Quantity384 cases containing 40 pads each for a total of 15,360 pads

Reason for Recall

Improper wire placement from the patient plate to the ESU connector plug results in an intermittent displacement connection.

Firm Action

A recall notification letter dated 09/30/2004 was sent to Hospitals and Health Care Distributors instructing consignees to immedately remove all effective product from lot 2007-06 HP.

Root Cause

Other

Distribution Pattern

The subject product lot was distributed to the following key 3M distributors: Owens & Minor, Cardinal Health, McKesson, Professional Health Supply, and the Burrows Company.

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.

↑