Home › Cerenovus, Inc. › CODMAN HAKIM BACTISEAL SIPHONGUARD RICKHAM

CODMAN HAKIM BACTISEAL SIPHONGUARD RICKHAM

Cerenovus, Inc. · Model NS5515 · UDI-DI 10886704048428

JXG Prescription

510(k) clearances

25,520

Adverse events (222 deaths)

108

Recalls

Facilities

Description

CODMAN HAKIM Precision Fixed Pressure Valve with BACTISEAL with SIPHONGUARD Device, Unitized RICKHAM Reservoir, Stainless Steel Base and Bactiseal Catheters Operating Pressure: 130mm H2O (1274Pa) High Range Includes: BACTISEAL Ventricular Catheter 14cm, Stylet, Unitized BACTISEAL Peritoneal Catheter 120cm, Priming Adapter and Information Manual

Recalls

Date	Firm	Reason
2026-04-10	Integra LifeSciences Corp. (NeuroSciences)	Out-of-specification endotoxin result that did not meet the acceptance criteria.
2024-12-16	Integra LifeSciences Corp.	Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
2024-12-16	Integra LifeSciences Corp.	Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
2024-12-16	Integra LifeSciences Corp.	Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
2024-05-07	Integra LifeSciences Corp.	Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
2024-05-07	Integra LifeSciences Corp.	Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
2024-05-07	Integra LifeSciences Corp.	Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
2023-11-28	Natus Medical Incorporated	Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
2023-11-28	Natus Medical Incorporated	Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
2023-06-28	Medtronic Neurosurgery	Product labeling contains incorrect expiration date

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.