Device Recall Quinton BETACAP Adapter 의 리콜

Recall

58845

Class 2

Z-2747-2011

2011-05-19

2011-07-06

Terminated

United States

2012-05-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100404

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.

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.