Drug recall
Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for burr…
FDA recall event 66949 · Class II · Integra LifeSciences Corp. d.b.a. Integra Pain Management
Key facts
| Event ID | 66949 |
|---|---|
| Recall numbers | Z-0551-2014 |
| Recalling firm | Integra LifeSciences Corp. d.b.a. Integra Pain Management |
| Product type | Devices |
| Products | Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits due to identified labeling discrepancies. kit contains DuraPrep and Monocryl sutures whose labeling… |
| Initiation date | Nov 26, 2013 |
| Report date | Jan 1, 2014 |
| Termination date | Apr 9, 2014 |
| City | Salt Lake City |
| State | UT |
| Country | United States |
| FEI number | 1000138491 |
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: