Recall Z-1679-2017 ยท KOC Accessories, Blood Circuit, Hemodialysis
Molded Products Inc
Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer.
| Date | Mar 24, 2017 (initiated Jan 20, 2015) |
| Status | Terminated |
| Reason | A customer relayed a complaint of a leaking dialysis tubing connector. |
| Root cause | Process control |
| Action | On 1/20/2015, the recalling firm requested the firm's customer to return units from the affected lot. |
| Quantity | 400 pieces |
| Distribution | Product was distributed to Ontario, Canada. |
| 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 |