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Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured ...

FDA Recall #Z-1080-2016 — Class II — December 18, 2015

Recall #Z-1080-2016 Date: December 18, 2015 Classification: Class II Status: Terminated

Product Description

Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks.

Reason for Recall

Potential for the parts to crack.

Recalling Firm

Value Plastics, Inc. — Fort Collins, CO

Classification

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

Product Type

Devices

Product Quantity

33,000

Distribution

3 Consignees in NY, PA, MN. No foreign, VA/govt.

Code Information

Catalog #: FCA026-001 Lot #s: 67775, 69321, 69814, 70178, 71812, 152127, 152903, 153015

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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