# FDA recall Z-2670-2017

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2017-04-04.

## Product

Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No.  EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.

## Reason for recall

Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation contained pin holes in the side wall of the hub. The defect was not detected during Smiths Medical incoming inspection. The syringe assemblies were used to manufacture seven (7) finished good lots of Hypodermic Needle Pro¿ needles, Smiths Medical part numbers EL 1915 and SB5021.

## Distribution

US Distribution to the state of : IN

## Key facts

- **Recall number:** Z-2670-2017
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-04-04
- **Report date:** 2017-07-12
- **Termination date:** 2019-08-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2670-2017

## Citation

> AI Analytics. FDA recall Z-2670-2017. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2670-2017. Source: US FDA. Licensed CC0.

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