Z-1162-03

Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter and Pressure Pump, 15 drops/mL, 99'', 170...

Name: Z-1162-03 Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter and Pressure Pump, 15 drops/mL, 99'', 170...
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 and Pressure Pump, 15 drops/mL, 99'', 170 to 260 Micro Filter, Large Standard Blood Filter, 2... 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-1162-03
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 and Pressure Pump, 15 drops/mL, 99'', 170 to 260 Micro Filter, Large Standard Blood Filter, 2 Injection Sites, Male Luer Lock Adapter, catalog 4C6723; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Product code: KSB Set, Transfer (Blood/Plasma)
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: 272,688 units
Distribution: Nationwide, Mexico, Canada, Columbia, Australia, New Zealand and Taiwan
Product codes and lots: catalog 4C6723, lot numbers UR150458 through UR166892. 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 KSB

K993120Class IIModified Blood Recipient SetBaxter Healthcare Corp / cleared 1999-11-17

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)