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Field reports on stuff that let you down

FDA device recallMedications· Medline Industries, LP

Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ…

Official notice from a government agency or its published feed.

Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D
Reason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution.

Hazard: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

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