Teleflex Medical Europe Ltd recalls Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 (c)…

Recall date

March 15, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1369-2018

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

Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 (c) 650704160 551316 Product Usage: RUSCH Simplastic Suprapubic Puncture Instruments are indicated for emergency suprapubic drainage of the bladder.