FDA Medical Device Recalls (openFDA)
Cordis Corporation: Vistabritetip IG Introducer, Introducer Guide. Labeled as sterile, sterilized with ethylene oxide gas. For single use only. Catalog number 4038553S
- Recall number
- Z-0588-05
- Recalling firm
- Cordis Corporation
- Product
- Vistabritetip IG Introducer, Introducer Guide. Labeled as sterile, sterilized with ethylene oxide gas. For single use only. Catalog number 4038553S
- Status
- Terminated
- Initiated
- 2004-05-05
- Posted
- 2005-03-10
- Terminated
- 2008-11-21
- Reason
- The product is labeled as Straight Catheter but the package contains Contralateral Guide shaped Catheters.
- Root cause
- Other
- Action
- A recall letter dated 04/30/2004 was sent to the consignees, instructing them to discontinue using the product and informed them that a Cordis representive would remove any unit in their possesion.
- Quantity
- 40
- Distribution
- Distributed in FL, OK, SC, and KS in the US. Internationaly to South Africa and the Netherlands.
- Lot, serial or model codes
- Lot # L0104244
- 510(k) numbers
- ["K001136"]
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 1016427
- Firm city
- Miami Lakes
- Firm state
- FL
- 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