Baxter Integrated APD Set Recalled for Leakage Complaints
Baxter Healthcare is recalling 8,640 units of Integrated APD Sets with Cassette 3-Prong due to leakage complaints. The sterile fluid path is used for peritoneal dialysis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a sterile medical device used for renal failure treatment where leakage compromises sterility, posing a risk of infection or harm, but no injuries or illnesses have been reported.
Plain-English summary
Baxter Healthcare Corp. is recalling one lot of Integrated Automated Peritoneal Dialysis (APD) sets with Cassette 3-Prong. The recall involves 8,640 units of the sterile, nonpyrogenic fluid path, which is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD Systems in clinical and home use settings.
The recall was initiated due to complaints received regarding leakage of the device. The affected lot code is H13L22013. The product was distributed nationwide in the United States, specifically in the states of FL, WI, AR, TN, TX, NC, MO, NM, NJ, CT, PA, NV, NY, CA, MI, KS, and OH.
Patients and healthcare providers should check their inventory for the specific lot code H13L22013. If the product is found, it should be stopped and returned to the distributor or manufacturer for replacement or refund.
The recalled product
- Product
- Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD Systems in clinical and home use s
- Manufacturer
- Baxter Healthcare Corp.
- Hazard
- Affected units
- 8,640
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- H13L22013
Distribution
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