Medical device recalls Moderate risk

Teleflex Medical Europe Ltd recalls Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520

Recall date
March 15, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1370-2018
FDA classification
Class II
Brand / firm
Teleflex Medical Europe Ltd
Sold / distributed
US Nationwide Distribution

Why it was recalled

These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

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

What was recalled

Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520

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