Recall Z-1893-2009 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Baxter Healthcare Corp.
Baxter Minicap Extended Life PD Transfer Set (6") with Twist Clamp; six sets per carton; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 5C4482 The set is used in disconnect applications and cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler juncture.
| Date | Aug 31, 2009 (initiated Jul 2, 2009) |
| Status | Terminated |
| Reason | The peritoneal dialysis transfer set has a defective white sleeve twist clamp. The twist clamp will not open or close completely, which could cause leakage and lead to peritonitis. |
| Root cause | Nonconforming Material/Component |
| Action | Baxter Healthcare Corporation telephoned the accounts receiving the affected lots and then faxed or e-mailed "Urgent Product Recall" letters dated July 2, 2009, to them, to the attention of the Peritoneal Dialysis Nurse, to inform them of the defective white sleeve twist clamp, which may result in leakage and possible peritonitis. The accounts were asked to immediately discontinue the use of the affected lot numbers and examine their inventory for the affected lots. If any affected product was found, they were requested to quarantine it and contact Baxter Center for Service at 1-888-229-0001 |
| Quantity | 714 sets |
| Distribution | US (states of Arkansas, Illinois, Mississippi, North Carolina, Tennessee and Virginia) and El Salvador. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K882498 | EXTENDED LIFE CAPD TRANSFER SET 5C4444 Baxter Healthcare Corp, Jul 13, 1988 |