FDA Device recall Z-2264-2016
Container fill and transfer sets, 250 mL and 500 mL, .
- FDA Device
- Class II
- terminated
- Published 2016-08-03
On 2016-08-03 the FDA classified a Class II recall of Container fill and transfer sets, 250 mL and 500 mL, . by The Metrix, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2264-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-23 |
| Published | 2016-08-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | The Metrix |
| Distribution | AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, WA |
Product
Container fill and transfer sets, 250 mL and 500 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.
Identifiers
| code_info | All lots are being recalled. Lot code consists of the five digit product code followed by a dash followed by a unique f…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: 66505 and 66510 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2264-2016%22
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