Recall Z-2263-2016
The Metrix Company · initiated June 23, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL
Codes / lots: 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: 66617, 66622, 66632, 66642, 69616, 69621, 69631, and 69641
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
On 6/23/2016, the recalling firm sent written recall notices to their distributors and end users notifying them of the recall. Customers and consignees were instructed to not use the devices, locate and quarantine all affected devices, and to complete the response form.
Details
- Recall number
- Z-2263-2016
- Initiated
- June 23, 2016
- Terminated
- April 11, 2023
- Product code
- NEP – System/Device, Pharmacy Compounding
- Quantity
- 18,474 case
- Distribution
- 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
- Recalling firm
- The Metrix Company, Dubuque, IA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2257-2016 Class II | AUTOCOMP6 XPS High Speed Compounder REF 58810An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the… | 06/23/2016Terminated |
| Z-2258-2016 Class II | AUTOCOMP6 XP High Speed Compounder REF 58810An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the… | 06/23/2016Terminated |
| Z-2259-2016 Class II | AUTOCOMP6 High Speed CompounderAn issue was identified after a redesign of the auto compounding device. The compounder cannot meet the… | 06/23/2016Terminated |
| Z-2260-2016 Class II | Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL.An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the… | 06/23/2016Terminated |
| Z-2261-2016 Class II | Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL…An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the… | 06/23/2016Terminated |
| Z-2262-2016 Class II | Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mLAn issue was identified after a redesign of the auto compounding device. The compounder cannot meet the… | 06/23/2016Terminated |
| Z-2264-2016 Class II | Container fill and transfer sets, 250 mL and 500 mL, . .An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the… | 06/23/2016Terminated |