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U.S. Department of Health and Human Services

Class 2 Device Recall Quinton BETACAP Adapter

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  Class 2 Device Recall Quinton BETACAP Adapter see related information
Date Initiated by Firm May 19, 2011
Date Posted July 06, 2011
Recall Status1 Terminated 3 on May 21, 2012
Recall Number Z-2747-2011
Recall Event ID 58845
Product Classification System, peritoneal automatic delivery - Product Code FKX
Product 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
Code Information All lots of Quinton BETA-CAP Adapters, product code 8814-661001, sold by Baxter under product code 5K4560
Recalling Firm/
Manufacturer		 Baxter Healthcare Renal Div
1620 Waukegan Rd
Mc Gaw Park IL 60085-6730
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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, Baxter recommends the clinician exercise extra caution and vigilance to ensure the connection between the Quinton BETA-CAP adapter and the Baxter Transfer Set is secured and tight. The clinicians were instructed to also check their inventory for the Quinton Beta Cap adapter 8814-661001 purchased directly from Baxter, and contact Baxter at 888-229-0001 to arrange for the return and credit of the unused product. Baxter recommends that the Covidien BETA CAP adapter no longer be used and to instead exclusively use the Baxter Titanium Adapter (5C4129) which has sufficient thread geometry for maintaining a secure connection with the Baxter Transfer Set. The customers were also instructed to complete and fax the enclosed customer reply form to (847) 270-5457, indicating the quantity of Quinton Beta Cap adapters being returned and acknowledging the understanding and dissemination of the information in the letter.
Quantity in Commerce 13,942 units
Distribution Class II Recall -- Nationwide Distribution
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.
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