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Terminated

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 Recall Z-1409-2017 · Posted None

Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeMMP
Date Initiated2017-01-23
Date Terminated2019-08-07
Product Quantity42,750 units

Reason for Recall

Sterility compromised due to breach in sterile barrier

Firm Action

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.

Root Cause

Packaging process control

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041501GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERSGuangzhou Fortunique , Ltd. · 2004-11-30

Official Source

View FDA Recall →

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

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