Recalls / —

—#45558

Product

Endopath Probe Plus II, Hook Electrode, 5 mm Shaft, 34 cm length, hollow tip electrdode, Product Code EPS01.

FDA product code

GCJ — Laparoscope, General & Plastic Surgery

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K912492

Affected lot / code info

Lots C4D111, C4DD09, C4DD0H, C4DE5L, C4DK67, C4DM01, C4DM03, and C4DN03.

Why it was recalled

There is the possibility of a seal void in the Probe Plus packaging which may 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 #45558. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.