Hospira Recalls HEXTEND Hetastarch Bags Due to Sterility Concerns
Hospira is recalling 11,412 bags of HEXTEND (Hetastarch) 6% Injection due to a potential leak from the fill tube seal 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the potential for sterility failure in an IV product is a significant hazard.
Plain-English summary
Hospira Inc. is recalling 11,412 bags of HEXTEND (Hetastarch) 6% in Lactated Electrolyte Injection, 500 mL. The product is a prescription-only intravenous solution manufactured and distributed by Hospira in Lake Forest, Illinois. The specific lot affected is # 10-199-JT with an expiration date of 10/13.
The recall was initiated due to a lack of assurance of sterility. There is a potential for the solution to leak from the seal of the fill tube to the bag, which could compromise the sterile integrity of the product. The FDA has classified this as a Class II recall.
The affected product was distributed nationwide. Healthcare providers and facilities should stop using the affected lot and contact Hospira for further instructions or returns. Patients who have received this product should consult their healthcare provider if they have concerns.
The recalled product
- Product
- HEXTEND (HETASTARCH)
- Brand
- HEXTEND
- Manufacturer
- Hospira Inc.
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 11,412
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 (1)
- Lot # 10-199-JT Exp. 10/13
Distribution
Distributed nationwide across the United States.
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