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Terminated

Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT

FDA Recall Z-1780-2019 · Posted None

Recalling FirmCook Inc.
Recall StatusTerminated
Product CodeKGZ
Date Initiated2019-05-02
Date Terminated2019-08-23
Product Quantity97

Reason for Recall

The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product.

Firm Action

Urgent Medical Device Recall notification letters dated 5/2/19 were sent to customers.

Root Cause

Under Investigation by firm

Distribution Pattern

No distribution in the US. Products were distributed to the following foreign countries: China.

Official Source

View FDA Recall →

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

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