Recall Z-0969-2013
Molded Products Inc · initiated June 19, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
Codes / lots: Lot numbers: 80106 and 80106b
Reason for recall
The recalled product leaks at the connection site.
FDA-determined cause: Process control
Action taken
The firm's one customer was notified of the recall by phone call on 5/8/2012. The customer returned the affected product once the replacement product was received.
Details
- Recall number
- Z-0969-2013
- Initiated
- June 19, 2012
- Posted by FDA
- March 18, 2013
- Terminated
- August 14, 2013
- Product code
- KOC – Accessories, Blood Circuit, Hemodialysis
- Quantity
- 1200 sets
- Distribution
- Distributed to one customer in Michigan.
- Recalling firm
- Molded Products Inc, Harlan, IA