PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 18, 2018 Initiated: March 15, 2018 #Z-1369-2018

Product Description

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.

Details

Units Affected
4220 units
Distribution
US Nationwide Distribution
Location
Athlone

Frequently Asked Questions

What product 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.. Recalled by Teleflex Medical Europe Ltd. Units affected: 4220 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 18, 2018. Severity: Moderate. Recall number: Z-1369-2018.