Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mL

Is this the product you have?

• Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mL

Lot codes and dates

• 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 product58733 and 58734

Amount recalled

3,829 cases

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

• AUTOCOMP6 XPS High Speed Compounder REF 58810
• AUTOCOMP6 XP High Speed Compounder REF 58810
• AUTOCOMP6 High Speed Compounder
• Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL.
• Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL…
• Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300…
• Container fill and transfer sets, 250 mL and 500 mL, . .

Where it was sold

• AL
• AZ
• CA
• CO
• CT
• FL
• IA
• IL
• KS
• LA
• MA
• MD
• MN
• NC
• OH
• PA
• PR
• TN
• TX
• UT
• WA

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.