Device Recall Baxter Minicap Extended Life PD Transfer Set (6")with Twist Clamp 의 리콜

Recall

52560

Class 2

Z-1893-2009

2009-07-02

2009-08-31

Terminated

United States

2010-07-08

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83310

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.

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 to arrange for its return to Baxter. The accounts were also requested to review their patient records to determine if any of their patients had received the affected product. If so, they were advised to contact the patients to see if they had experienced any leaking. If so, the patients should return to the facility to have the set changed per the facility's transfer set change procedure. Any questions were directed to the Center for One Baxter at 1-800-422-9837, Monday through Friday, 8:00 a.m. to 5:00 p.m. Central Standard Time (CST). The accounts were requested to complete the enclosed reply form acknowledging receipt of the letter and that they followed the instructions and disseminated the information to their staff.