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

Valleylab Laparoscopic Straight Spatula Electrode 36C Item Code: E277036 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable

FDA Recall Z-2561-2016 · Posted None

Recalling FirmMedtronic
Recall StatusTerminated
Product CodeGEI
Date Initiated2016-07-08
Date Terminated2018-08-08
Product Quantity13516

Reason for Recall

Potential for compromise of the package resulting in a breach of the sterile barrier

Firm Action

Medtronic/Covidien sent an Urgent Medical Device Recall letter dated July 8, 2016, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. The letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Customers with questions were instructed to contact their Medtronic representative or Customer Service at 800-882-5878.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

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.

↑