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Merit Medical Systems, Inc. recalls Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for
Recalled August 22, 2018 · FDA recall Z-2823-2018 · Merit Medical Systems
Hazard
Mix-up between adult and pediatrics PD catheter. · FDA Class II
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Worldwide Distribution - US Nationwide in the states of AL, CA, DE, FL, KY, MA, MO, NC, NY, OH, PA, and UT and the countries of Germany
Description
Mix-up between adult and pediatrics PD catheter.
Product
Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck¿ PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the FlexNeck PD Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC¿ System of peritoneoscopic implantation enable inspection of the peritoneum to confirm the presence of adhesions and to avoid them, all patients who are suitable for PD can receive this catheter.
Manufacturer(s)
Merit Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →