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
This recall has been terminated (originally issued January 23, 2017).
- Company
- Covidien Llc
- Recall Initiated
- January 23, 2017
- Terminated
- August 7, 2019
- Recall Number
- Z-1409-2017
- Quantity
- 42,750 units
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility compromised due to breach in sterile barrier
Distribution
Nationwide
Lot / Code Info
Lot Numbers: 1410577-4 to 1605778
Root Cause
Packaging process control
Action Taken
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.
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