# FDA recall Z-0575-2018

> **B. Braun Medical, Inc.** · Class II · device recall initiated 2017-06-21.

## Product

Pain Management Tray. Product Catalog Number: 560602.    Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

## Reason for recall

B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been  identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product  development process.

## Distribution

US Nationwide Distribution.

## Key facts

- **Recall number:** Z-0575-2018
- **Recalling firm:** B. Braun Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-21
- **Report date:** 2018-02-21
- **Termination date:** 2018-04-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allentown, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0575-2018

## Citation

> AI Analytics. FDA recall Z-0575-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0575-2018. Source: US FDA. Licensed CC0.

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