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B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antib...

FDA Recall #Z-0921-2014 — Class II — December 13, 2013

Recall #Z-0921-2014 Date: December 13, 2013 Classification: Class II Status: Terminated

Product Description

B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.

Reason for Recall

Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications.

Recalling Firm

B. Braun Medical, Inc. — Allentown, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

30, 240 units

Distribution

US Distribution one importer/wholesale distributor in MO.

Code Information

Catalog #CT-2000-100lots 3H0125F151 and 3H0225F151, expiration 7/2018.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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