Recall Z-0341-04 ยท KGZ Accessories, Catheter
Baxter Healthcare Corp.
Baxter Lineo Opticap Disconnect Cap, product codes R5C4599Q (English) and N5C4599Q (dual English/French label); Baxter Healthcare Corporation, Deerfield, IL 60015 USA; 30 units per case
| Date | Jul 20, 2004 (initiated Dec 5, 2003) |
| Status | Terminated |
| Reason | Reports of loosening of the connections and disconnection of the device. |
| Root cause | Other |
| Action | Baxter sent recall letters dated 12/5/03 to the accounts in the United Kingdom and recall letters dated 12/8/03 to the accounts in Canada, informing them of the reports of loosening of the connections and disconnection of the device, and requesting that they discontinue use of product codes involved and revert the enrolled patients back to their traditional connection system. |
| Quantity | 4,920 units |
| Distribution | Canada and the United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031676 | HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q Baxter Healthcare Corp, Nov 20, 2003 |