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

Endopath Probe Plus II, Needle Electrode, 5mm shaft, 29cm length, hollow tip electrode, Code EPS09.

FDA Recall Z-0924-06 · Posted 2006-05-31

Recalling FirmEthicon Endo-Surgery Inc
Recall StatusTerminated
Product CodeGCJ
Date Initiated2006-04-20
Date Terminated2012-09-26
Product Quantity24 cases/6 devices per case.

Reason for Recall

There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.

Firm Action

The recalling firm sent a recall letter by United Parcel Services to all consignees for delivery to each consignee on 4/24/06. The letter requested subaccount address return information to the recalling firm.

Root Cause

Packaging process control

Distribution Pattern

The recalled product was distributed throughout the United States and to foreign consignees including Argentina, Australia, Austria, Bahrain, Brazil, Canada, China, Colombia, Czech Republic, Dominican Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Korea, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K912492EVACUATION/IRRIGATION/ELECROSURGICAL DEVICEETHICON, Inc. · 1991-10-21

Official Source

View FDA Recall →

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

↑