The Recall Desk
HighFDA (Drugs)·D-0948-2018·Announced 2018-07-25

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.

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 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
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.

See all 38 products in this recall →