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Class 2 Device Recall |
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Date Initiated by Firm |
April 21, 2006 |
Date Posted |
July 04, 2006 |
Recall Status1 |
Terminated 3 on March 06, 2012 |
Recall Number |
Z-1190-06 |
Recall Event ID |
35358 |
510(K)Number |
K945993
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Product Classification |
Vaporizer, Anesthesia, Non-Heated - Product Code CAD
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Product |
Vapofils with Stainless Steel Block Ends, Item Number V0507S (Sevofluane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle to the vaporizer. |
Code Information |
Lot Numbers: S07275, S02086, S10215, S08315, S02286, S12095, S12195, S12215, S02216, & S03096 |
Recalling Firm/ Manufacturer |
Southmedic Inc Po Box 1365 Barrie Canada Ontario
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For Additional Information Contact |
James A. Dunning 480-703-3631
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Manufacturer Reason for Recall |
Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia and surgery, and may damage certain plastic equipment. Leakage may also expose patients to low concentrations of volatile anesthetics.
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FDA Determined Cause 2 |
Other |
Action |
Recall letters were sent to both US consignees via US Postal Service delivery with signature receipt required on April 21, 2006. Each letter included a Recall and Effectiveness Check Form for each consignee to fill out and fax to Southmedic.
U.S. and international consignees were instructed to examine inventory immediately to identify if they have any product on hand, discontinue the distribution of these products and return all affected products to Southmedic.
Consignees were also instructed to immediately notify their customers if they have further distributed these products.
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Quantity in Commerce |
186 in US (403 Worldwide) |
Distribution |
US in FL & NJ
Worldwide in Australia, Belgium, Ecuador, Germany, Japan, Netherlands, Sri Lanka, Taiwan, & United Arab Emerates |
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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510(K) Database |
510(K)s with Product Code = CAD and Original Applicant = SOUTHMEDIC, INC.
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