Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2823-2018 — 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 P

U.S. FDA — Device Enforcement · United States · 2017-12-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2823-2018
Date of alert: 2017-12-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Merit Medical Systems, Inc.
Product category: device
Product type: Devices

Reported risk: Mix-up between adult and pediatrics PD catheter.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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