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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm April 21, 2006
Date Posted July 04, 2006
Recall Status1 Terminated 3 on March 06, 2012
Recall Number Z-1189-06
Recall Event ID 35358
510(K)Number K945993  
Product Classification Vaporizer, Anesthesia, Non-Heated - Product Code CAD
Product Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle to the vaporizer.
Code Information Lot numbers : I02156, I07205, I03096, I02286, & I12095
Recalling Firm/
Manufacturer		 Southmedic Inc
Po Box 1365
Barrie Canada Ontario
For Additional Information Contact James A. Dunning
480-703-3631
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.
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.
Quantity in Commerce 69 in US (211 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
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.
510(K) Database 510(K)s with Product Code = CAD and Original Applicant = SOUTHMEDIC, INC.
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