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Class 2 Device Recall IPI & Medex Water Trap with "Y" for Ventilator Circuits |
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Date Initiated by Firm |
July 12, 2004 |
Date Posted |
July 22, 2004 |
Recall Status1 |
Terminated 3 on February 07, 2005 |
Recall Number |
Z-1125-04 |
Recall Event ID |
29496 |
Product Classification |
Drain, Tee (Water Trap) - Product Code BYH
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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 |
Recalling Firm/ Manufacturer |
Medex Inc 6250 Shier Rings Rd Dublin OH 43016-1270
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For Additional Information Contact |
Ms. Terri Davis 800-848-1757 Ext. 5542
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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.
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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 |
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
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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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