# FDA recall D-0944-2018

> **Avella of Deer Valley, Inc. Store 38** · Class II · drug recall initiated 2018-06-12.

## Product

fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacaine HCL PF, USP, 250 mg, 0.9% Sodium Chloride, USP QS 250 mL. Volume: 250mL. Single dose Cassette. For: Methodist St. John Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-250-87

## Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0944-2018
- **Recalling firm:** Avella of Deer Valley, Inc. Store 38
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-06-12
- **Report date:** 2018-07-25
- **Termination date:** 2020-01-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Phoenix, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0944-2018

## Citation

> AI Analytics. FDA recall D-0944-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0944-2018. Source: US FDA. Licensed CC0.

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