Baxter recalls leaking peritoneal dialysis transfer sets
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Baxter Healthcare issued a voluntary recall for some lots of its peritoneal dialysis transfer sets due to the potential for leaks and no flow, the company told Healio Nephrology.
The leaking in the MiniCap Extended Life PD Transfer Set (#5C4482) is coming from under the product’s twist clamp, Jill D. Carey-Hargrave, of global corporate communications for Baxter International Inc., wrote in an email to Healio Nephrology. “We have notified the FDA and providers, and patients are in the process of being notified,” Carvey-Hargrave said. “Patients who are not experiencing no-flow or leak complications are advised to continue use of their transfer sets under supervision of their dialysis provider and should follow clinic procedures to monitor and manage their home care.”
In a three-page letter sent to dialysis providers on Nov. 10, 2020, Baxter said the lots with the defective transfer sets were distributed between June 30, 2020 and Aug. 14, 2020 in the United States. “The most common complaints Baxter has observed have been no-flow conditions of PD solutions from the transfer sets,” according to the letter. “The patient may experience a delay in therapy as the product may not allow for the required flow. This may require the patient to go to the dialysis clinic for a new transfer set.
“Damaged or leaking transfer set tubing could result in microbial contamination of the sterile fluid path. This may predispose patients to peritonitis. Baxter has received one report of peritonitis possibly related to this issue,” according to the letter.
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