Class 2 Device Recall IPI & Medex Water Trap with "Y" for Ventilator Circuits

• Date Initiated by Firm: July 12, 2004
• Date Posted: July 22, 2004
• Recall Status: Terminated on February 07, 2005
• Recall Number: Z-1125-04
• Recall Event ID: 29496
• Product Classification: Drain, Tee (Water Trap) - Product Code BYH
• Product: Disposable Water Trap with ''Y'' for Ventilator Circuits; product reorder 6091; SIngle Patient Use only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008
• Code Information: reorder no. 6691, lots H197, J057, J147, J174, J216, J267, K070, K311, L171, L275, M225, M343, N065, N178, N233
• FEI Number: 1526863
• 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: 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: 4,204 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.