Medical device recalls Moderate risk

Abbott Laboratories, Inc recalls Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.

Recall date
September 29, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0166-2018
FDA classification
Class II
Brand / firm
Abbott Laboratories, Inc
Sold / distributed
Worldwide distribution to US, Canada, France, and Germany.

Why it was recalled

The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.

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