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Recall Observatory FDA recall evidence

Device product

Foot control irrigation system Product Usage: Pneumatic system

Z-1933-2017

October 06, 2016

Class II

Product summary

Firm
The Anspach Effort, Inc.
Event
Event 76059
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-1933-2017

Official wording

Reason: Supplied Directions for Use (DFU) did not contain a recommended service interval.

Code information: All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AL-III-IRR

Distribution pattern: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Supplied Directions for Use (DFU) did not contain a recommended service interval.