Recall Z-0969-2013 ยท KOC Accessories, Blood Circuit, Hemodialysis
Molded Products Inc
Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
| Date | Mar 18, 2013 (initiated Jun 19, 2012) |
| Status | Terminated |
| Reason | The recalled product leaks at the connection site. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 1200 sets |
| Distribution | Distributed to one customer in Michigan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003712 | MODIFICATION TO MALE TO MALE LUER ADAPTER Molded Products, Inc., May 16, 2001 |