Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL.

Reason: An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.

Code information: All lots are being recalled. Lot code consists of the five digit product code followed by a dash followed by a unique five character numeric or alphanumeric sequence. Affected product codes for this product: 58781, 58785, 62005, 62010, 62015, 62025, 62030, 62035, 64005, 64010, 64015, 64025, 64030, 64035, 64781, 65005, 65010, 65015, 65025, 65030, 65035, 66005, 66010, 66015, 66020, 66025, 66030, 66035, 66305, 66310, 66315, 66325, 66330, 66335, 66705, 66710, 66715, 66725, 66730, 66735, 66910, 66915, 66925, 66930, 66935, 67005, 67010, 67015, 67025, 67030, 67035, 69005, 69010, 69015, 69025, 69030, 69035

Distribution pattern: Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom