Z-2747-2011

Quinton BETA-CAP Adapter; a Peritoneal Dialysis accessory to the PD catheter used to connect the catheter to...

Name: Z-2747-2011 Quinton BETA-CAP Adapter; a Peritoneal Dialysis accessory to the PD catheter used to connect the catheter to...
Creator: Baxter Healthcare Renal Div
Published: 2011-05-19
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2011-05-19 / Terminated

FDA source

Baxter Healthcare Renal Div began a recall of 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... on 2011-05-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2747-2011
Status: Terminated
Initiated: 2011-05-19
Posted: 2011-07-06
Terminated: 2012-05-21
Recalling firm: Baxter Healthcare Renal Div
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
Product code: FKX System, Peritoneal, Automatic Delivery
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 root cause: 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
Product codes and lots: All lots of Quinton BETA-CAP Adapters, product code 8814-661001, sold by Baxter under product code 5K4560

Product code FKX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)