FDA Enforcement
Class II
Terminated
Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly that has been damaged.
Recall: Z-2802-2020
·
Reported August 19, 2020
Enforcement
- Recall Number
- Z-2802-2020
- Event ID
- 86044
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Arrow International Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 19, 2020
- Initiation Date
- July 6, 2020
- Classification Date
- August 13, 2020
- Termination Date
- November 5, 2021
- Address
- 2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States
Description
Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly that has been damaged.
Reason
The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.
Code Info
Product Code: CAR-02400 Lot #: 13F19J0153 and 23F17H0547
Distribution
World wide distribution
Quantity
N/A