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Terminated

MedRo Rx -Reverse Osmosis System All Models All Voltages, All Voltages

FDA Recall Z-0798-05 · Posted 2005-05-06

Recalling FirmU.S. Filter/Ionpure, Inc.
Recall StatusTerminated
Product CodeFIP
Date Initiated2005-02-28
Date Terminated2012-05-15
Product Quantity282 units

Reason for Recall

Incorrect type of stainless steel firm used 303 vs 316

Firm Action

US Filter notified consignees by letter between 3/17 and 3/28/05 advising users of the recall.US Service will field correct and replace units.

Root Cause

Other

Distribution Pattern

Nationwide Foreign: Canada, Mexico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030652MEDRO SPDUsfilter/Ionpure, Inc. · 2003-09-03

Official Source

View FDA Recall →

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

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