Recall Z-0006-2020
The Metrix Company · initiated September 21, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Codes / lots: Lot Numbers: 66641-A2630, 66641-A2683, 66641-A3005, 66641-A3560, 66641-A3796, 66641-A3979, 66641-A4220, 66641-A4473, 66641-A4543, 66641-A5066, 66641-A5283, 66641-A5412, 66641-A5556, 66641-A5671
Reason for recall
Potential for leaking product
FDA-determined cause: Process control
Action taken
The Metrix Company notified the direct account (distributors) by telephone on 09/21/2019. The firm asked if the consignees received any complaints of leaking during the divider rod removal and return of any of the lot. The firm expanded the recall and disseminated the notices by email and telephone on 08/2/30/2019. Press was issued on 09/09/2019.
Details
- Recall number
- Z-0006-2020
- Initiated
- September 21, 2018
- Product code
- KPE – Container, I.V.
- Quantity
- 54720 bags
- Distribution
- US Nationwide distribution including the states of PA, MA, IL CA.
- Recalling firm
- The Metrix Company, Dubuque, IA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0001-2020 Class II | SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 -…Potential for leaking product | 09/21/2018Open, Classified |
| Z-0002-2020 Class II | SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 -…Potential for leaking product | 09/21/2018Open, Classified |
| Z-0003-2020 Class II | SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 -…Potential for leaking product | 09/21/2018Open, Classified |
| Z-0004-2020 Class II | SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian…Potential for leaking product | 09/21/2018Open, Classified |
| Z-0005-2020 Class II | SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian…Potential for leaking product | 09/21/2018Open, Classified |
| Z-0007-2020 Class II | ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500…Potential for leaking product | 09/21/2018Open, Classified |
| Z-0008-2020 Class II | ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250…Potential for leaking product | 09/21/2018Open, Classified |