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U.S. Department of Health and Human Services

Class 2 Device Recall Premier Guard Sterile Drape

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  Class 2 Device Recall Premier Guard Sterile Drape see related information
Date Initiated by Firm January 23, 2017
Create Date March 04, 2017
Recall Status1 Terminated 3 on August 07, 2019
Recall Number Z-1408-2017
Recall Event ID 76327
510(K)Number K041501  
Product Classification Cover, barrier, protective - Product Code MMP
Product Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046)
Item Number: 01-0020

Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
Code Information Lot Numbers: 1112351 to 1609891
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact SAME
203-492-5000
Manufacturer Reason
for Recall		 Sterility compromised due to breach in sterile barrier
FDA Determined
Cause 2		 Packaging process control
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.
Quantity in Commerce 1,111,600 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MMP and Original Applicant = GUANGZHOU FORTUNIQUE LTD.
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