—#152794

Product

Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures

FDA product code: MMP — Cover, Barrier, Protective
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K041501
Affected lot / code info: Lot Numbers: 1410577-4 to 1605778

Why it was recalled

Sterility compromised due to breach in sterile barrier

Root cause (FDA determination)

Packaging process control

Action the firm took

Medtronic issued recall letter on January 23, 2017. Customers were notified via Federal Express and the letter instructed customers to discontinue use of the product and return all inventory to Medtronic (Covidien) 195 McDermott Road, North Haven, CT 06473 Attn: Field Returns Department.

Recalling firm

Firm: Covidien LLC
Address: 60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2017-01-23
Terminated: 2019-08-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152794. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.