Avella Recalls Heparin Bags Due to Potential Leakage and Sterility Concerns
Avella of Deer Valley, Inc. is recalling 40 bags of Heparin 1,000 Units in NS 250mL due to potential leakage that compromises sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk-of-harm product (sterility compromise) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Avella of Deer Valley, Inc. is recalling 40 single-dose bags of Heparin 1,000 Units in NS 250mL (NDC 42852-747-25). The product was prepared for Adventist Medical Center Hanford and distributed nationwide in the USA.
The recall was initiated due to a lack of assurance of sterility caused by potential leakage of the bags. The affected lot number is 5/1/18 0511 515-74725P, with a beyond-use date of July 30, 2018.
Healthcare facilities and consumers should stop using the affected product and contact the recalling firm for further instructions or returns.
The recalled product
- Product
- HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 mL) Volume: 251 mL. Single dose bag. For: Adventist Medical Center Hanford. By: Avella of Huston, 9265 Kirby Dr., Houston TX, 77054. NDC 42852-747-25
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Category
- Drug — IV Infusion
- Affected units
- 40
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 #: 5/1/18 0511 515-74725P
- BUD 7/30/2018.
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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