FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
- Recall number
- Z-0194-2016
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
- Status
- Terminated
- Initiated
- 2015-10-06
- Posted
- not on file
- Terminated
- 2016-06-27
- Reason
- Leakage from the inlet port of the 15L Cycler Drainage Bags.
- Root cause
- Under Investigation by firm
- Action
- Baxter sent an Urgent Product Recall letter dated October 8, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recalling firm will ask customers to locate and separate all affected products, contact the recalling firm to arrange for a return, and complete the customer reply form. Further questions, please call (800) 422-9837.
- Quantity
- 19,440 units
- Distribution
- US Distribution and Internationally to Canada.
- Lot, serial or model codes
- H15C11095
- 510(k) numbers
- ["K791899"]
- PMA numbers
- not on file
- Product code
- KDJ
- Firm FEI
- 1417572
- Firm city
- Deerfield
- 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