Medline angiography and radiology convenience kits 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 clearance. The recall affects 113,843 kits distributed nationwide and to Barbados.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Unapproved design changes to medical devices used in invasive procedures (angiography, radiology) without FDA review represent a risk of harm. Per the rubric, Class II recalls with risk of harm are scored as Severe (4).
Plain-English summary
Medline Industries, LP is recalling convenience kits containing select SKUs of 10mL polycarbonate colored syringes. The recalled kits include ANGIO PACK, ANGIO PACK-LF, ANGIO TRAY, ANGIOGRAM TRAY, ANGIOGRAPHY DRAPE PK QVH-LF, ANGIOGRAPHY PACK, ANGIOGRAPHY PACK-LF, GENERAL ANGIO PACK, GENERAL ENDO PACK-LF, JUDKINS PACK, RADIOLOGY ANGIO MAJOR PACK, and TAVR JUDKINS PACK, with a total of 113,843 kits recalled.
The manufacturer identified unapproved design changes to the products that were made outside of the 510(k) clearance granted by the FDA. These products were not initially reported in FDA Resolution (RES) 98601.
The affected kits were distributed US nationwide, 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 Barbados. Specific lot numbers and UDI identifiers are listed on the FDA's recall database.
Customers who have received these kits should stop using them and contact Medline Industries, LP for instructions on return or replacement.
The recalled product
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46153A ANGIOGRAM TRAY DYNJ33638K ANGIOGRAPHY DRAPE PK QVH-LF DYNJ35110D ANGIOGRAPHY…
- Manufacturer
- Medline Industries, LP
- Affected units
- 113,843
Distribution
Part of a larger recall action
This product is one of 16 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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