Device Recall Sabraset Administration Sets with Auto Clamp

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

General Hospital and Personal Use Devices

2

No

Nationwide, including Puerto Rico, and internationally to Australia, Belgium, Canada, Hong Kong, Israel, Japan, Singapore, Sweden and Switzerland

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