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U.S. Department of Health and Human Services

Class 2 Device Recall IPI Ventilator Circuit with 2 Water Traps

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  Class 2 Device Recall IPI Ventilator Circuit with 2 Water Traps see related information
Date Initiated by Firm July 12, 2004
Date Posted July 22, 2004
Recall Status1 Terminated 3 on February 07, 2005
Recall Number Z-1122-04
Recall Event ID 29496
Product Classification Set, Tubing And Support, Ventilator (W Harness) - Product Code BZO
Product IPI Ventilator Circuit with 2 Water Traps, product reorder no. 6066; SIngle Patient Use Only; Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641
Code Information reorder no. 6066, lot L050
Recalling Firm/
Manufacturer		 Medex Inc
6250 Shier Rings Rd
Dublin OH 43016-1270
For Additional Information Contact Ms. Terri Davis
800-848-1757 Ext. 5542
Manufacturer Reason
for Recall		 The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
FDA Determined
Cause 2		 Other
Action Medex telephoned the direct accounts on 7/12/04, and will fax and mail follow-up recall letters dated 7/2/04 on 7/13/04, informing them that the affected products were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containing latex. The accounts were requested to cease distribution/use of the affected lots and return them to Medex for free replacement. The accounts were asked to contact Customer Service at 1-800-848-1757 to make arrangements for the return and replacement of their affected product. Distributors were requested to sub-recall the products from their customers. Any questions were directed to Terri Davis at 1-800-848-1757, ext. 5542.
Quantity in Commerce 400 units
Distribution California, Colorado, Connecticutt, Florida, Georgia, Illinois, Indiana, Kansas, New Jersey, New York, Tennessee and Texas.
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.
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