Bracco recalls Empower FastLoad CT Syringe Packs due to insufficient sterile barrier seals, risking contamination. Affected units sold with EmpowerCT, EmpowerCTA, and EmpowerCTA+ systems. Contact for remedy.
Insufficient seal on the sterile barrier of the device, compromising the sterility of the device
Bracco is recalling sterile syringe kits for CT scans because the packaging may not seal properly, risking contamination. This could lead to infections if used improperly. Affected kits were sold with specific CT scanner models.
The syringe packs have a seal that may not close properly, allowing contaminants to enter the sterile packaging. This could lead to infections if the syringe is used without proper sterility.
Healthcare professionals using the Empower FastLoad CT Syringe Packs with EmpowerCT, EmpowerCTA, or EmpowerCTA+ systems are most at risk. Patients receiving contrast media via these syringes could be affected if the packaging fails.
Check for the SKU 017344/6720 on the packaging. The product was sold with EmpowerCT, EmpowerCTA, or EmpowerCTA+ injector systems. Lot numbers start with IANBL-1804.
Look for SKU 017344/6720 and lot number IANBL-1804 on the packaging.
Bracco recalls Empower FastLoad CT Syringe Packs due to insufficient sterile barrier seals that could compromise sterility.
Check for SKU 017344/6720 and lot number IANBL-1804 on the packaging. The product was sold with EmpowerCT, EmpowerCTA, or EmpowerCTA+ systems.
The recall record does not specify a remedy, so contact Bracco directly for instructions.
We’ve drafted a message you can send Bracco to request your refund or repair — edit it as you like.
Subject: Recall Z-0654-2019 — Bracco Bracco Hello, I own a Bracco that is covered by recall Z-0654-2019 from Bracco. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
