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Terminated

6 cm Catheter Reservoir with 10 cm extension

FDA Recall Z-0365-06 · Posted 2006-01-10

Recalling FirmVygon Neuro
Recall StatusTerminated
Product CodeHCA
Date Initiated2005-03-24
Date Terminated2006-01-10
Product Quantity49 units

Reason for Recall

stylet in package is shorter than that claimed on the label

Firm Action

The recalling firm issued a letter to their customers informing them of the problem and the need to return the product.

Root Cause

Other

Distribution Pattern

The product was shipped to a hospital in CA and a distributor in Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K853362H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETERHolter-Hausner Intl. · 1985-09-03K853361H-H VENTRICULAR CATHETERS & RESERVOIRSHolter-Hausner Intl. · 1985-08-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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