Drug recall
Blood-Pack Unit with an Integral Bioflex RC Leukocyte Reduction Filter Using CPD/Adsol Red Cell Preservation…
FDA recall event 94017 · Class II · Fenwal Inc
Key facts
| Event ID | 94017 |
|---|---|
| Recall numbers | B-0212-2024, B-0213-2024, B-0214-2024, B-0215-2024, B-0216-2024, B-0217-2024, B-0218-2024, B-0219-2024, B-0220-2024 |
| Recalling firm | Fenwal Inc |
| Product type | Biologics |
| Products | Blood-Pack Unit with an Integral Bioflex RC Leukocyte Reduction Filter Using CPD/Adsol Red Cell Preservation Solution for Whole Blood Collection and Filtration of Red Blood Cells, Product Code 4R1784…, Blood-Pack Unit with an Integral Bioflex RC Leukocyte Reduction Filter Using CPD/Adsol Red Cell Preservation Solution for Whole Blood Collection and Filtration of Red Blood Cells, Product Code 4R1787…, Blood-Pack Unit with an Integral Bioflex RC Leukocyte Reduction Filter Using CPD/Adsol Red Cell Preservation Solution for Whole Blood Collection and Filtration of Red Blood Cells, Product Code 4R3440…, Blood-Pack Unit with an Integral Fenwal Bioflex RC Leukocyte Reduction Filter Using CPD/Adsol Red Cell Preservation Solution for Whole Blood Collection and Filtration of Red Blood Cells and Fenwal…, Fenwal Blood-Pack Units Using Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) and Fenwal HighFlo Needle, Product Code 4R1782, NDC 0942-6504-02, CPD/ADSOL DBL BIOFLEX Y-SITE… and 4 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Fenwal International, Inc. (a Fresenius Kabi Company) is initiating a voluntary recall for certain lots of Fenwal Blood-Pack Unit product codes due to an elevated presence of bacteria that was found… |
| Initiation date | Feb 15, 2024 |
| Report date | Mar 6, 2024 |
| Termination date | Jun 27, 2024 |
| City | Lake Zurich |
| State | IL |
| Country | United States |
| FEI number | 3004548776 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: