# FDA recall Z-1978-2020

> **Access Scientific LLC** · Class II · device recall initiated 2020-04-23.

## Product

BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick Kit. REF/UDI / 94114/10859821006220 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.

## Reason for recall

Saline Flush Syringe compromised sterility due to holes in the packaging.

## Distribution

US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA.

## Key facts

- **Recall number:** Z-1978-2020
- **Recalling firm:** Access Scientific LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-23
- **Report date:** 2020-05-20
- **Termination date:** 2021-04-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1978-2020

## Citation

> AI Analytics. FDA recall Z-1978-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-1978-2020. Source: US FDA. Licensed CC0.

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