Medline Polycarbonate Syringes in Convenience Kits Recalled for Unapproved Design Changes
Medline Industries recalled multiple convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The company identified these modifications and notified the FDA of the deviation from the approved 510(k) design.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is a Class II FDA medical device recall involving unapproved design changes outside of 510(k) clearance for syringes used in clinical settings (cardiac catheterization, interventional procedures). Class II recalls with potential for significant harm to health require a Severe classification.
Plain-English summary
Medline Industries, LP is recalling convenience kits containing select 10mL polycarbonate colored syringes. The kits are sold under various names including Angio Drape Pack, Angio Pack, Angiography Pack, Cardiac Cath Pack, Cath Lab Pack, Interventional Radiology Pack, and other hospital-related kits. The affected kits contain multiple SKUs identified by product codes such as DYNJ47665D, DYNJ30565D, DYNJ0854485V, and many others listed with corresponding lot numbers and UDI codes.
The recall was initiated after Medline identified unapproved design changes to the products that were made outside of the FDA's 510(k) clearance. These modifications deviate from the design that the FDA originally cleared. The affected products were not initially reported in RES 98601.
The recalled kits have been distributed nationwide throughout the United States, including in Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin, Wyoming, and also to Barbados. A total of 113,843 kits are affected.
Customers who have purchased these kits should stop using them and contact Medline for further instructions regarding return or replacement options.
The recalled product
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665D ANGIO PACK DYNJ30565D ANGIOGRAPHY PACK-LF DYNJ0854485V ARTERIOGRAM DYNJ28082D DYNJ28082F CARDIAC CATH DYNJ67349 CARDIA
- Manufacturer
- Medline Industries, LP
- Hazard
- design-deviation
- unapproved-modification
Distribution
Distributed nationwide across the United States.
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