Drug recall
CPD/ADSOL DOUBLE BIOFLEX Y-SITE, Product Code 6R1782, NDC number 0942-6514-03 Fenwal Blood-Pack Units Using…
FDA recall event 97023 · Class II · Fenwal Inc
Key facts
| Event ID | 97023 |
|---|---|
| Recall numbers | B-0379-2025, B-0380-2025 |
| Recalling firm | Fenwal Inc |
| Product type | Biologics |
| Products | CPD/ADSOL DOUBLE BIOFLEX Y-SITE, Product Code 6R1782, NDC number 0942-6514-03 Fenwal Blood-Pack Units Using Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) with an Integrally Attached…, CPD/ADSOL TRIPLE BIOFLEX SAMPLE DIVERSION PL146 PL2209, Product Code 4R1787, NDC number 0942-6507-03 Blood-Pack Unit with an Integral Bioflex RC Leukocyte Reduction Filter Using CPD/Adsol Red Cell… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | In this situation, Fenwal International (a Fresenius Kabi Company) is initiating a voluntary recall for one lot of Fenwal Blood-Pack Unit due to an elevated presence of bacteria that was found in… |
| Initiation date | May 27, 2025 |
| Report date | Jul 23, 2025 |
| Termination date | Oct 8, 2025 |
| 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: