Medline Convenience Kits with 10mL Syringes recalled for unapproved design changes
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed nationwide and internationally.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for an unapproved design change. The source text does not report any illnesses, injuries, or known adverse events, and the hazard remains theoretical rather than realized.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes, including Extremity Pack, Hand Pack, Laminectomy, Major Extremity, and Podiatry Pack models. The products were subject to design changes that were implemented outside the scope of the FDA 510(k) clearance.
The recalled kits were distributed worldwide, including throughout the United States, Canada, Panama, and Barbados. A total of approximately 270,311 units are affected by this recall. Multiple lot numbers are associated with the recalled products; specific lot information is available through the FDA recall notice and customer letters issued by Medline.
Customers in possession of affected Convenience Kits should discontinue use and contact Medline Industries for further instructions regarding the recalled products.
The recalled product
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C HAND PACK DYNJ83218A, DYNJ85396 LAMINECTOMY DYNJ905156R MAJOR EXTREMITY DYNJ905159L, DYNJ905159M MAJOR EXTREMITY PACK DYNJ69926A PODIATRY PACK D
- Manufacturer
- Medline Industries, LP
- Hazard
- unapproved-design-change
Distribution
Distributed nationwide across the United States.
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