FDA (Devices) recall action 94583
The FDA (Devices) publishes a recall like this one as 81 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 81 pages.
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
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The agency’s own wording, quoted from the enforcement report.
Medline is recalling CYSTO PACK convenience kits containing defective plastic syringes with leaks and breakage that may risk patient health. Affected worldwide; specific lot numbers provided.
Medline is recalling surgical convenience kits with plastic syringes that may leak or break. The defects pose a risk to patient safety during procedures.
Medline is recalling convenience kits containing plastic syringes with quality issues including leaks and breakage that may affect patient safety. The kits have been distributed worldwide.
Medline is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose a risk to patient health. The recall affects multiple syringe products distributed worldwide.
Medline Industries is recalling convenience kits containing plastic syringes with leaks, breakage, and quality defects identified by an FDA Safety Alert. These defects may pose risks to patient safety during medical procedures.
Medline is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. The kits are distributed worldwide for procedures including dialysis and spinal procedures. The defects may pose a risk to patient health.
Medline is recalling medical convenience kits containing plastic syringes that may leak or break. These quality defects, linked to an FDA safety alert, pose a potential risk to patient health.
Medline Industries is recalling multiple medical convenience kits containing plastic syringes that may leak or break, posing a risk to patient health. The affected kits have been distributed worldwide.
Medline medical convenience kits containing plastic syringes are being recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The FDA Safety Alert issued March 19, 2024, identifies affected syringes used in multiple types of medical procedures.
Medline Convenience kits containing plastic syringes are being recalled due to leaks, breakage, and quality issues that may pose a risk to patient health. Multiple kit types have been distributed worldwide.
Medline Convenience kits with plastic syringes affected by an FDA safety alert are being recalled due to leaks, breakage, and quality issues that may harm patients.
Medline Industries is recalling multiple medical convenience kits containing plastic syringes with quality defects including leaks and breakage. These defects may pose a risk to patient health.
Medline is recalling medical convenience kits containing plastic syringes with identified quality defects including leaks and breakage. The worldwide-distributed kits may pose a risk to patient health.
Medline Industries is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose patient safety risks. The recall affects multiple pack types distributed worldwide.
Medline Convenience kits containing defective plastic syringes are being recalled worldwide due to leaks, breakage, and quality issues that may pose patient health risks.
Medline is recalling multiple medical convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The recall affects kits distributed worldwide.
Medline Industries is recalling medical convenience kits containing plastic syringes with leaks, breakage, and other quality issues that may pose a risk to patient health.
Medline is recalling vascular IVC filter placement kits containing defective plastic syringes due to leaks and breakage that may pose health risks. The affected kits are distributed worldwide.
Medline medical convenience kits containing defective plastic syringes are being recalled due to leaks, breakage, and quality issues. The affected devices have been distributed worldwide and may pose a risk to patient health.
Medline Convenience kits containing plastic syringes are recalled worldwide due to leaks, breakage, and quality issues posing risks to patients. Multiple lot numbers from 2020–2023 are affected.
Medline is recalling Tonsil & Adenoid surgical convenience kits containing defective plastic syringes. The kits may leak or break, posing risks to patient safety.
Medline Industries is recalling multiple convenience kits containing plastic syringes with identified quality issues including leaks and breakage. These defects may pose a risk to patient health.
Medline is recalling medical convenience kits containing syringes due to quality issues including leaks and breakage. These defects may pose a risk to patient health and were identified in relation to an FDA Safety Alert issued March 19, 2024.
Medline is recalling medical convenience kits with plastic syringes that may leak or break, posing a risk to patient health. Worldwide distribution is affected.
Medline is recalling medical convenience kits with plastic syringes that may leak or break. The FDA issued a safety alert due to quality defects that could harm patients.