CODMAN EVD BACTISEAL 1 — Class II medical device recall Z-2137-2024
Ongoing recall by Integra LifeSciences Corp., reported 2024-06-19, distributed nationwide. Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise t
| Recall number | Z-2137-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2024-05-07 |
| Classified | 2024-06-12 |
| Reported by FDA | 2024-06-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, HR, HU, RU, SG, SI, TR, TW, ZA |
| Quantity | 106 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10381780518440 |
| Lot numbers | 7314912, 7320010, 7322933 |
Product
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) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821749
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2137-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.