Z-2801-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2020
- Initiation Date
- July 6, 2020
- Termination Date
- November 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit permits access to the epidural space.
Reason for Recall
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.
Distribution Pattern
World wide distribution
Code Information
Product Code: AK-03000-S Lot #: 13F17J0230