# FDA recall Z-1369-2018

> **Teleflex Medical Europe Ltd** · Class II · device recall initiated 2018-03-15.

## 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

- **Recall number:** Z-1369-2018
- **Recalling firm:** Teleflex Medical Europe Ltd
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1369-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1369-2018. Source: US FDA. Licensed CC0.

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