—#45975

Product

Endopath Probe Plus II, Open End Suction/Irrigation Canula, 10mm shaft, 34 cm length, Code EPS11.

FDA product code: GCJ — Laparoscope, General & Plastic Surgery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K912492
Affected lot / code info: Lot code C4DL3J.

Why it was recalled

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

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Ethicon Endo-Surgery Inc
Address: 4545 Creek Rd, Cincinnati, Ohio 45242-2803

Distribution

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.

Timeline

Recall initiated: 2006-04-20
Posted by FDA: 2006-05-31
Terminated: 2012-09-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #45975. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.