Z-2086-2019 Class II Terminated
FDA device recall Z-2086-2019 was initiated by Teleflex Medical on July 1, 2019 and is designated Class II. Reason for recall: Potential for product not to be sterile. The recall status is terminated (terminated November 4, 2021). Affected quantity: 3,700 devices.
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2019
- Initiation Date
- July 1, 2019
- Termination Date
- November 4, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,700 devices
Product Description
Rusch EasyCath Kit
Reason for Recall
Potential for product not to be sterile.
Distribution Pattern
Nationwide distribution to CA, FL, IL, NC, NJ, OH, OK, TX.
Code Information
Catalog Number ECK120, Lot Number 74C1900304, Expiration Date 03/01/2022. Catalog Number ECK125, Lot Number 74B1901676, Expiration Date 06/01/2022.