Ventilator Circuit with ''Y'' & elbow with 2 Water Traps, for use with/compatible with Bennett 7200; product...
Medex Inc began a recall of Ventilator Circuit with ''Y'' & elbow with 2 Water Traps, for use with/compatible with Bennett 7200; product reorder 6072WT; SIngle Patient Use only; IPI label... on . The reason FDA records is "The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-1123-04
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Abbott Medical
- Product
- Ventilator Circuit with ''Y'' & elbow with 2 Water Traps, for use with/compatible with Bennett 7200; product reorder 6072WT; 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
- Product code
- BZO Set, Tubing And Support, Ventilator (W Harness)
- 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.
- Root cause tag
- labeling and UDI
- FDA root 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
- 940 units
- Distribution
- California, Colorado, Connecticutt, Florida, Georgia, Illinois, Indiana, Kansas, New Jersey, New York, Tennessee and Texas.
- Product codes and lots
- reorder no. 6072WT, lots B16C002, M156, M261, N090, N160
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