FDA Enforcement
Class II
Terminated
Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
Recall: Z-2758-2017
·
Reported August 2, 2017
Enforcement
- Recall Number
- Z-2758-2017
- Event ID
- 77686
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cardinal Health 200, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 2, 2017
- Initiation Date
- June 27, 2017
- Classification Date
- July 24, 2017
- Termination Date
- March 29, 2019
- Address
- 1500 S Waukegan Rd, N/A, Waukegan, IL, 60085-6728, United States
Description
Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
Reason
Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.
Code Info
Lot 16LUS317, expires November 1, 2021
Distribution
Worldwide Distribution - US (Nationwide including PR) and Canada
Quantity
528 each