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
Reported: March 15, 2017 Initiated: January 23, 2017 #Z-1409-2017
Product Description
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
Reason for Recall
Sterility compromised due to breach in sterile barrier
Details
- Recalling Firm
- Covidien LLC
- Units Affected
- 42,750 units
- Distribution
- Nationwide
- Location
- North Haven, CT
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Covidien LLC. Units affected: 42,750 units.
Why was this product recalled? ▼
Sterility compromised due to breach in sterile barrier
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 15, 2017. Severity: Moderate. Recall number: Z-1409-2017.
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