FDA-Device2018-04-18Class II
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.
Teleflex Medical Europe Ltd
Hazard
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.
Sold states
US Nationwide Distribution
Affected count
4220 units
Manufactured in
Ida Business Park, Athlone, Ireland
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1369-2018Don't want to check this manually?
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