Avella Recalls Fentanyl and Bupivacaine Cassettes Due to Sterility Concerns
Avella of Deer Valley, Inc. is recalling 15 cassettes of fentanyl and bupivacaine due to potential bag leakage and lack of sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medication (fentanyl) with a potential sterility failure (leakage), which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Avella of Deer Valley, Inc. is recalling 15 single-dose cassettes containing fentanyl 3 mcg/mL and 0.1% bupivacaine. The recall is being conducted because of a lack of assurance of sterility, specifically due to potential leakage of the bags.
The affected product is identified by Lot # 5/14/18 0913 320-25087Y with a beyond-use date of 6/28/2018. The cassettes were distributed nationwide in the USA and were intended for Methodist St. John Hospital. The product was manufactured by Advanced Pharma.
Consumers and healthcare providers should stop using the affected cassettes and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- 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 15082-250-8
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 5/14/18 0913 320-25087Y
- BUD 6/28/2018.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 38 recalled by Avella of Deer Valley, Inc. Store 38 under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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