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U.S. Department of Health and Human Services

Class 2 Device Recall Replacement Gauge

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  Class 2 Device Recall Replacement Gauge see related information
Date Initiated by Firm May 19, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on September 14, 2004
Recall Number Z-1232-04
Recall Event ID 29184
Product Classification Apparatus, Suction, Operating-Room, Wall Vacuum Powered - Product Code GCX
Product Boehringer Replacement Gauge Model 9071, Lot Number 200405.
Code Information Lot Number 200405
Recalling Firm/
Boehringer Laboratories Inc
500 E Washington St
Norristown PA 19401-5149
For Additional Information Contact John Karpowicz
Manufacturer Reason
for Recall
The suction regulator incorporates a gauge for the verification of suction levels. The particular lot of gauges used in the production of the regulators exhibits a potential to develop a leak and cause the delivered suction to be inaccurate.
FDA Determined
Cause 2
Action All direct accounts were contacted by the recalling firm''s Customer Service Representative to determine the location of the affected product. The CSR arrange for replacement proudct.
Quantity in Commerce 9 units
Distribution The recalled product was distributed to the following states: AL, FL, MA, MI, OR, PA, TN,
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.