• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Replacement Gauge

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  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/
Manufacturer
Boehringer Laboratories Inc
500 E Washington St
Norristown PA 19401-5149
For Additional Information Contact John Karpowicz
800-642-4945
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
Other
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.
-
-