FDA Medical Device Recalls (openFDA)
Medex Inc: 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
- Recall number
- Z-1122-04
- Recalling firm
- Medex Inc
- 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
- Status
- Terminated
- Initiated
- 2004-07-12
- Posted
- 2004-07-22
- Terminated
- 2005-02-07
- Reason
- 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
- 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
- 400 units
- Distribution
- California, Colorado, Connecticutt, Florida, Georgia, Illinois, Indiana, Kansas, New Jersey, New York, Tennessee and Texas.
- Lot, serial or model codes
- reorder no. 6066, lot L050
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BZO
- Firm FEI
- 1526863
- Firm city
- Dublin
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28