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URGENT: FIELD SAFETY NOTICE (Correction) Specific product codes and lots of Protein Latex Micro Surgical Gloves Event202003257 XX October 2020 Attention: Risk Management Director and O.R. Materials
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Who needs field safety notice correction?

01
Manufacturers of medical devices or other regulated products who have identified a need to correct safety issues or update information related to their products.
02
Distributors or retailers of these products who have received notifications of field safety notice corrections from manufacturers and need to take appropriate actions.
03
Healthcare providers or facilities that have received affected products and need to implement the necessary corrections or updates to ensure patient safety.
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Field safety notice correction is a document that provides information about corrective actions taken to address safety issues related to a medical device.
Manufacturers, distributors, and authorized representatives of medical devices are required to file field safety notice correction.
Field safety notice correction can be filled out by providing detailed information about the safety issue, corrective actions taken, affected products, and contact information for further inquiries.
The purpose of field safety notice correction is to inform users and regulatory authorities about safety issues related to medical devices and the actions taken to address them.
Field safety notice correction must include information about the safety issue, affected products, corrective actions taken, contact information, and any relevant references to previous communications.
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