FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 89'', 170 to 260 Micron Filter, Large Bore Tubing, Male Luer Lock Adapter, catalog 4C7776A; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
- Recall number
- Z-1163-03
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 89'', 170 to 260 Micron Filter, Large Bore Tubing, Male Luer Lock Adapter, catalog 4C7776A; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
- Status
- Terminated
- Initiated
- 2003-07-16
- Posted
- 2003-08-21
- Terminated
- 2004-06-29
- Reason
- There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Root cause
- Other
- Action
- Recalled by letter dated 7/16/03. The accounts were informed of the potential for leaks in the set tubing, and asked to inspect their inventory for the affected product codes and lots, segregate any affected products found and discard them according to local procedures. The customers will receive credit for the discarded affected product.
- Quantity
- 21,024 units
- Distribution
- Nationwide, Mexico, Canada, Columbia, Australia, New Zealand and Taiwan
- Lot, serial or model codes
- catalog 4C7776A, lot numbers UR160143 through UR166538. Please note: Baxter lot numbers are represented by an internal reference code ''UR'' followed by a six digit sequential number, or by the letter ''U'' followed by a six digit sequential number with and ''R'' suffix. Any lot number appearing within the identified six digit sequential number range is subject to the recall.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BRZ
- Firm FEI
- 1416980
- Firm city
- Round Lake
- 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