Z-1086-05

Baxter Sabraset 6060 Administration Set with Pre-attached 250 mL Bag and Cassette, product code 560500-250...

Name: Z-1086-05 Baxter Sabraset 6060 Administration Set with Pre-attached 250 mL Bag and Cassette, product code 560500-250...
Creator: Baxter Healthcare Corp.
Published: 2005-05-04
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2005-05-04 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Baxter Sabraset 6060 Administration Set with Pre-attached 250 mL Bag and Cassette, product code 560500-250; Manufactured for Baxter Healthcare Corporation... on 2005-05-04. The reason FDA records is "The inlet and outlet lines of the administration set may be reversed, which would result in reverse flow". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1086-05
Status: Terminated
Initiated: 2005-05-04
Posted: 2005-08-06
Terminated: 2006-07-21
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Sabraset 6060 Administration Set with Pre-attached 250 mL Bag and Cassette, product code 560500-250; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Mexico
Product code: FPA Set, Administration, Intravascular
Reason for recall: The inlet and outlet lines of the administration set may be reversed, which would result in reverse flow.
FDA root cause: Other
Action: Baxter sent Urgent Device Correction letters dated 5/4/05 to their customers, to the attention of the Director of Nursing, via first class mail on the same date. The accounts were informed of the one complaint of reverse assembly of the administration set, and were provided with diagrams showing the configuration of a correct assembly and an incorrect assembly of the sets. The accounts were instructed to inspect the sets carefully before use to assure correct assembly. The accounts were requested to destroy any misassembled sets found and complete the certificate of destruction enclosed with the letter, faxing it back to Baxter at 847-270-5457 to receive credit for the destroyed sets.
Quantity in commerce: 7,516 sets
Distribution: Nationwide and internationally to Australia, Belgium, Canada and Japan.
Product codes and lots: product code 560500-250, lots 417521, 418481, 418744

Product code FPA

K002679Class II6060 Multi-Therapy Pump, Model 2M9832; 6060 Epidural Pump, Model 2L9351Baxter Healthcare Corp / cleared 2000-09-18

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)