Arrow International Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) recall — FDA Z-1974-2018
Product sterility may be compromised due to unsealed packaging.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Product sterility may be compromised due to unsealed packaging.
Product sterility potentially compromised.
Product sterility may be compromised due to unsealed packaging.
Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle…
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
There is a potential for a software issue that may cause the need for necessary patient rescans.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle…
Product sterility may be compromised due to unsealed packaging.
Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.
The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
Product sterility may be compromised due to unsealed packaging.
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