Z-0386-05

Sabraset Administration Sets with AutoClamp; for use with model 6060 multi-therapy pumps only; a...

Name: Z-0386-05 Sabraset Administration Sets with AutoClamp; for use with model 6060 multi-therapy pumps only; a...
Creator: Baxter Healthcare Corp.
Published: 2004-11-19
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2004-11-19 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Sabraset Administration Sets with AutoClamp; for use with model 6060 multi-therapy pumps only; a prescription, sterile, non-pyrogenic fluid pathway... on 2004-11-19. The reason FDA records is "A missing platen assembly in the cassette of the solution sets results in the infusion pump being unable to occlude the tubing of the set. This can lead to free-flow of the solution and a possible overdose of medication...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0386-05
Status: Terminated
Initiated: 2004-11-19
Posted: 2005-01-08
Terminated: 2006-06-28
Recalling firm: Baxter Healthcare Corporation
Product: Sabraset Administration Sets with AutoClamp; for use with model 6060 multi-therapy pumps only; a prescription, sterile, non-pyrogenic fluid pathway; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., the following sets were made in Mexico: a) Sabraset 56050 100 Administration Set with 100 mL Bag and Cassette, 56'', Volume 3 mL, 100 mL Bag with Fill Port, Cassette with AutoClamp Device, Slide Clamp, Male Luer Lock Adapter b) Sabraset 56050 250 Administration Set with 2500 mL Bag and Cassette, 53'', Volume 3 mL, 250 mL Bag with Fill Port, Cassette with AutoClamp Device, Slide Clamp, Male Luer Lock Adapter
Product code: FPA Set, Administration, Intravascular
Reason for recall: A missing platen assembly in the cassette of the solution sets results in the infusion pump being unable to occlude the tubing of the set. This can lead to free-flow of the solution and a possible overdose of medication to the patient.
FDA root cause: Other
Action: Urgent Product Recall letters dated 11/19/04 were sent to the direct accounts on the same date via UPS ground. The accounts were informed that free-flow situations were associated with the listed product codes and lot numbers due to a missing platen assembly in the cassette of the solution sets, which could result in an overdose of medication to the patient. The accounts were requested to stop use of the affected lot numbers and product codes and return the sets to Baxter c/o NNC Group, 2670 Executive Dr., Indianapolis, IN 46241, following the enclosed instructions. Any questions concerning the return process were directed to NCC at 1-866-300-5085. Any medical or technical questions were directed to Baxter at 1-800-422-9837.
Quantity in commerce: 1,355,820 sets
Distribution: Nationwide, including Puerto Rico, and internationally to Australia, Belgium, Canada, Hong Kong, Israel, Japan, Singapore, Sweden and Switzerland
Product codes and lots: Product codes 560500-100 and 560500-250, all lot numbers other than lots produced within the range of 417519 to 499999, or those with an adhesive circular colored sticker (Avery dot) at the top of the individual package on the Tyvek side or on the shipper label. Any lot numbers from the following obsolete Sabraset product codes are also being recalled: 5600PM, 560100, 560101, 560110, 560111, 560112, 560112-GEL, 560112-L, 560113, 560115, 560116, 560122-L, 561101, 567100, 567100-L, 567112-L, 567122-L, 569100, 569111, 569122, 560200-100, 560522-100

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)