FDA Medical Device Recalls (openFDA)
Cardinal Health: Jackson-Pratt Hemaduct, 15 Fr round, full duct silicone wound drain; a sterile, single use only, Rx device, individually packaged, 10 drains per box, 8 boxes per case; catalog #JP-HUR880; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA
- Recall number
- Z-1406-04
- Recalling firm
- Cardinal Health
- Product
- Jackson-Pratt Hemaduct, 15 Fr round, full duct silicone wound drain; a sterile, single use only, Rx device, individually packaged, 10 drains per box, 8 boxes per case; catalog #JP-HUR880; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA
- Status
- Terminated
- Initiated
- 2004-07-28
- Posted
- 2004-08-25
- Terminated
- 2005-02-10
- Reason
- The products labeled as sterile are not sterile.
- Root cause
- Other
- Action
- The accounts were telephoned on 7/28/04 and sent follow-up letters on the same date. They were informed that affected lots of products were not sterile, and were requested to inspect their inventory and segregate the product for return to Cardinal Health. The accounts were instructed to call 800-635-6021 for product return and instructions on how to obtain credit and replacement product.
- Quantity
- 110 cases
- Distribution
- Florida, Arizona, New Jersey and Canada
- Lot, serial or model codes
- catalog #JP-HUR880, lot 1040909
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GCY
- Firm FEI
- 3001236905
- Firm city
- McGaw Park
- Firm state
- IL
- 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