Z-1163-03

Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 89'', 170 to 260 Micron...

Name: Z-1163-03 Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 89'', 170 to 260 Micron...
Creator: Baxter Healthcare Corp.
Published: 2003-07-16
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2003-07-16 / Terminated / root cause: packaging

FDA source

Baxter Healthcare Corp. began a recall of 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... on 2003-07-16. The reason FDA records is "There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1163-03
Status: Terminated
Initiated: 2003-07-16
Posted: 2003-08-21
Terminated: 2004-06-29
Recalling firm: Baxter Healthcare Corporation
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
Product code: BRZ Set, Blood Transfusion
Reason for recall: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
Root cause tag: packaging
FDA 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 in commerce: 21,024 units
Distribution: Nationwide, Mexico, Canada, Columbia, Australia, New Zealand and Taiwan
Product codes and lots: 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.

Product code BRZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)