Hospira Recalls Sterile Empty Vials Due to Leaking During Filling
Hospira is recalling sterile empty vials and injectors because they may leak during filling and administration. The recall covers products distributed in the US, Canada, Costa Rica, and the Virgin Islands.
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 medical device with a defect (leaking) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Hospira, Inc. is recalling Sterile Empty Vial and Injector (30mL PCA vial) products, List No. 6021-03. The recall was initiated due to reports of leaking during the filling and administration of the vials. These products are prescription-only and are intended for use with compatible Hospira PCA pump sets and infusion devices.
The affected products were distributed worldwide, including in the United States, Canada, Costa Rica, and the Virgin Islands. The recall letter was issued for all product presently in the field and product that will be released. Specific lot numbers were not indicated in the recall letter.
Hospira is the recalling firm. No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take, such as stopping use or contacting a provider.
The recalled product
- Product
- Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device.
- Manufacturer
- Hospira, Inc.
- Category
- Medical Device — Infusion Vials
- Hazard
Distribution
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