Z-0969-2013 Class II Terminated
FDA device recall Z-0969-2013 was initiated by Molded Products Inc on June 19, 2012 and is designated Class II. Reason for recall: The recalled product leaks at the connection site. The recall status is terminated (terminated August 14, 2013). Affected quantity: 1200 sets.
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2013
- Initiation Date
- June 19, 2012
- Termination Date
- August 14, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1200 sets
Product Description
Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
Reason for Recall
The recalled product leaks at the connection site.
Distribution Pattern
Distributed to one customer in Michigan.
Code Information
Lot numbers: 80106 and 80106b