FDA Recalls Custom Tubing Extensions Due to Potential Cracking

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extensions, Model Number FCA026-001. The recall is being conducted by Value Plastics, Inc. The reason for the recall is the potential for the parts to crack.

The affected products were manufactured by Value Plastics dba Nordson MEDICAL and packaged in bags consisting of 100, 500, or 1,000 stopcocks. A total of 33,000 units are subject to this recall. The products were distributed to three consignees located in New York, Pennsylvania, and Minnesota. No foreign or government distribution is reported.

The specific lot numbers affected are 67775, 69321, 69814, 70178, 71812, 152127, 152903, and 153015. The FDA classifies this as a Class II recall, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product

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.

Manufacturer

Value Plastics, Inc.

Category

Medical Device — Tubing

Hazard

• cracking

Affected units

33,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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