Drug & medication recalls Moderate risk

Avella of Deer Valley, Inc. Store 38 product recalled over sterility concerns

Recall date
June 12, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Avella of Deer Valley, Inc. Store 38 recalls 0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose pump. For…
Recall number
D-0928-2018
FDA classification
Class II
Brand / firm
Avella of Deer Valley, Inc. Store 38
Sold / distributed
Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility: Potential leakage of bags.

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

What was recalled

0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose pump. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77056. NDC: 42852-661-02

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