FDA Enforcement
Class II
Terminated
Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case
Recall: Z-3046-2017
·
Reported August 30, 2017
Enforcement
- Recall Number
- Z-3046-2017
- Event ID
- 77917
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cardinal Health 200, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 30, 2017
- Initiation Date
- July 28, 2017
- Classification Date
- August 21, 2017
- Termination Date
- December 26, 2017
- Address
- 1500 S Waukegan Rd, Waukegan, IL, 60085-6728, United States
Description
Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case
Reason
Product 29474 LAVH drape was packaged as 29574 Robotic Drape with Leggings.
Code Info
Lot number 17DAH349
Distribution
US Distribution to the states of : NC, UT, OR, NY,TX, GA, NJ and FL.
Quantity
200 units