Drug recall
CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of…
FDA recall event 94622 · Class II · Integra LifeSciences Corp.
Key facts
| Event ID | 94622 |
|---|---|
| Recall numbers | Z-2136-2024, Z-2137-2024, Z-2138-2024 |
| Recalling firm | Integra LifeSciences Corp. |
| Product type | Devices |
| Products | CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining…, CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other…, CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF)… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility., Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility. |
| Initiation date | May 7, 2024 |
| Report date | Jun 19, 2024 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3003418325 |
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: