—#173103

Product

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

FDA product code: KGZ — Accessories, Catheter
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: lot 8373482

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

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

Timeline

Recall initiated: 2019-05-02
Terminated: 2019-08-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173103. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.