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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Minicap Extended Life PD Transfer Set Extra SHort (4") with Twist Clamp

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  Class 2 Device Recall Baxter Minicap Extended Life PD Transfer Set Extra SHort (4") with Twist Clamp see related information
Date Initiated by Firm July 02, 2009
Date Posted August 31, 2009
Recall Status1 Terminated 3 on July 08, 2010
Recall Number Z-1894-2009
Recall Event ID 52560
510(K)Number K882498  
Product Classification Set, administration, for peritoneal dialysis, disposable - Product Code KDJ
Product Baxter Minicap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp; six sets per carton; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 5C4483 The set is used in disconnect applications and cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler juncture.
Code Information Product code 5C4483, lot number H09E18044.  
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 2,436 sets
Distribution US (states of Arkansas, Illinois, Mississippi, North Carolina, Tennessee and Virginia) and El Salvador.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KDJ and Original Applicant = BAXTER HEALTHCARE CORP.
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