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

Recall Z-2162-2017 — CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is design

U.S. FDA — Device Enforcement · United States · 2017-02-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2162-2017
Date of alert: 2017-02-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: CORPAK MedSystems, Inc.
Product category: device
Product type: Devices

Reported risk: Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.

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

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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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