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Terminated

Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

FDA Recall Z-0830-2018 · Posted None

Recalling FirmCook Inc.
Recall StatusTerminated
Product CodeKNT
Date Initiated2017-10-19
Date Terminated2019-04-16
Product Quantity615

Reason for Recall

Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.

Firm Action

On October 19, 2017 an URGENT MEDICAL DEVICE RECALL letter was mailed to customers requesting that they examine inventory for affected product, immediately quarantine and return product to recalling firm for credit. Questions or concerns can be directed to 1-800-457-4500 or 812-330-2235.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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