Drug recall
Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary…
FDA recall event 69249 · Class II · Biomedix, Inc.
Key facts
| Event ID | 69249 |
|---|---|
| Recall numbers | Z-0023-2015 |
| Recalling firm | Biomedix, Inc. |
| Product type | Devices |
| Products | Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigation and found… |
| Initiation date | Aug 14, 2014 |
| Report date | Oct 15, 2014 |
| Termination date | Nov 13, 2014 |
| City | Bloomington |
| State | IN |
| Country | United States |
| FEI number | 1000115518 |
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: