Baxter Healthcare Corp. Rt. 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 w Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 w
Brand
Baxter Healthcare Corp. Rt.
Lot Codes / Batch Numbers
Product codes 560500-100 and 560500-250, all lot numbers other than lots produced within the range of 417519 to 499999, 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
Products Sold
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
Baxter Healthcare Corp. Rt. is recalling Sabraset Administration Sets with AutoClamp; for use with model 6060 multi-therapy pumps only; a pre due to 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 l. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026