FDA recall Z-1369-2018

Product

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.

Reason for recall

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.

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2018-03-15

Report date

2018-04-18

Termination date

2020-10-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Athlone, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1369-2018