Recall Z-2747-2011 ยท FKX System, Peritoneal, Automatic Delivery
Baxter Healthcare Renal Div
Quinton BETA-CAP Adapter; a Peritoneal Dialysis accessory to the PD catheter used to connect the catheter to the PD transfer set; Covidien product code 8814-661001, Baxter product code 5K4560
| Date | Jul 6, 2011 (initiated May 19, 2011) |
| Status | Terminated |
| Reason | A change made in the Quinton BETA-CAP adapter used to connect the patient PD catheter to the Baxter transfer set has resulted in a reduction in thread engagement which may lead to an increased risk of separation and the potential to develop peritonitis. |
| Root cause | Component change control |
| Action | Baxter sent an URGENT PRODUCT RECALL letter dated May 19, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The letter described the problem of loose connections when using the Quinton BETA-CAP with Baxter transfer sets. Baxter requested the dialysis centers to contact their patients currently using a Quinton BETA-CAP adapter to schedule an office visit with their attending physician as soon as practical to have the connection inspected or replaced. If they choose to continue use of the Quinton BETA-CAP adapter |
| Quantity | 13,942 units |
| Distribution | Class II Recall -- Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.