Bracco Recalls Empower FastLoad CT Syringe Packs Due to Seal Defect
Bracco is recalling 33,350 Empower FastLoad CT Syringe Packs because an insufficient seal on the sterile barrier may compromise the device's sterility.
The agency’s classification
FDA (Devices): 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 is classified as FDA Class II. The hazard involves a compromised sterile barrier on a medical device used for intravenous administration, which poses a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Bracco Injeneering S.A. is recalling 33,350 packs (667 cases) of Empower FastLoad CT Syringe Packs. These sterile, disposable syringe kits are designed for use with EmpowerCT, EmpowerCTA, and EmpowerCTA+ Injector Systems to facilitate the intravenous administration of contrast media and flushing solutions. The affected units are identified by Lot # IANBL-1804 and UDI (01) 17630039300309 (17) 210420 (11) 180420 (10) IANBL-1804.
The recall was initiated because of an insufficient seal on the sterile barrier of the device. This defect compromises the sterility of the syringe packs, which are intended for use in the human vascular system. The affected products were distributed nationwide in the United States.
Healthcare facilities and consumers should check their inventory for the specific lot number and UDI listed above. If the product is found, it should be removed from use and returned to Bracco Injeneering S.A. according to the company's instructions.
The recalled product
- Product
- Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA¿+ Injector Systems SKU 017344/6720 Empower FastLoad" CT Syringe Pack is a sterile, disposable syringe kit designed for use with EmpowerCT¿, EmpowerCTA¿…
- Manufacturer
- Bracco Injeneering S.A.
- Category
- Medical Device — Syringe Kits
Distribution
Distributed nationwide across the United States.
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