Medline medical procedure kits recalled for plastic syringe defects
Medline procedure kits with plastic syringes are being recalled due to potential leaks and breakage that may affect patient safety. The recall impacts 1152 units distributed nationwide and in Canada.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification combined with identified defects to angiography procedure kits (a high-risk medical device) qualifies this as High severity. The absence of reported illnesses or injuries prevents a higher score, per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling 1152 units of medical convenience kits labeled as Angiography Specials. The kits contain plastic syringes that have been identified as affected by an FDA Safety Alert issued on March 19, 2024.
The recalled kits have leaks, breakage, and other quality issues that may pose a risk to patient health. These defects could potentially compromise the safety and effectiveness of angiography procedures.
The affected kits have been distributed nationwide in the United States and to Canada. The specific lot affected is Pack Number DYNJ60655D.
Healthcare facilities and providers who have received these kits should stop using them and contact Medline Industries for a replacement or return. Patients who may have been affected by procedures performed with these kits should contact their healthcare provider.
The recalled product
- Product
- Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure Kit
- Hazard
- syringe-leak
- syringe-breakage
- quality-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 1) Pack Number DYNJ60655D: UDI/DI 10195327464783 (each)
- 40195327464784 (case)
- Lot Number 24AMC692A
Distribution
Distributed nationwide across the United States.
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