| Date Initiated by Firm | May 19, 2004 |
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| Date Posted | July 20, 2004 |
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| Recall Status1 |
Terminated 3 on September 14, 2004 |
| Recall Number | Z-1232-04 |
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| 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. |
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| 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 |
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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. |
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FDA Determined
Cause 2 | Other |
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| 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. |
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| Quantity in Commerce | 9 units |
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| Distribution | The recalled product was distributed to the following states: AL, FL, MA, MI, OR, PA, TN, |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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