Recall Z-1369-2018— Teleflex Medical Europe Ltd
Class II · Terminated
Class II FDA medical device recall by Teleflex Medical Europe Ltd, initiated 2018-03-15, terminated 2020-10-05. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Teleflex Medical Europe Ltd
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-15
- Terminated
- 2020-10-05
- Firm location
- Athlone, Ireland
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.