Recall Z-2823-2018— Merit Medical Systems, Inc.

Name: FDA recall Z-2823-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-20

Class II · Terminated

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2017-12-20, terminated 2020-10-29. It names one FDA 510(k) clearance: K970159. 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.. Reason: Mix-up between adult and pediatrics PD catheter..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-12-20
Terminated: 2020-10-29
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K970159 — FLEX-NECK PD CATHETERJanin Group, Inc.·cleared 1997-09-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Mix-up between adult and pediatrics PD catheter.

Data sourced from openFDA. This site is unofficial and independent of the FDA.