Medline polycarbonate 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 clearance.
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: The FDA classified this as a Class II recall. Unapproved design changes to medical devices used in critical clinical procedures such as cardiac catheterization and angiography present a potential for serious injury. Per the rubric, Class II recalls with potential for harm are scored as Severe.
Plain-English summary
Medline Industries, LP is recalling approximately 113,843 convenience kits containing select SKUs of 10mL polycarbonate colored syringes. The kits are used in angiography, cardiac catheterization, and other clinical procedures. The recall includes products with the following designations: ANGIO CATH COMBINED PACK, ANGIO PACK, ANGIO SPECIAL PROCEDURE-LF, ANGIOGRAM SET UP PACK, ANGIOGRAPHY PACK, CARDIAC CATH PACK, CATH LAB ANGIO TRAY, CATH LAB PACK, NEUROLOGICAL CATH PACK, OR HYBRID-MRMC, and STEWARD OR ANGIO PACK GSS.
The firm identified unapproved design changes to the products that were made outside of the scope of the 510(k) clearance granted by the FDA. These products were not initially reported in the original RES 98601 recall.
The affected kits were distributed nationwide in the states of Alabama, Arkansas, Arizona, 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 the country of Barbados.
Healthcare facilities and providers who have received these kits should discontinue use and contact Medline Industries for instructions on returns or replacements.
The recalled product
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO CATH COMBINED PACK DYNJ43609S ANGIO PACK DYNJ67987D DYNJ80317A ANGIO SPECIAL PROCEDURE-LF DYNJ38412C ANGIOGRAM SET UP PACK DYNJ66260A ANGIOGRAPHY PACK DYNJ44293I ANGIOGRA
- Manufacturer
- Medline Industries, LP
- Hazard
- unapproved-design-change
- regulatory-non-compliance
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 (2)
- DYNJ43609S UDI-DI 10195327322984 Lot 23BMG740
- DYNJ67987D UDI-DI 10195327265496 Lot 22LMI014
Distribution
Distributed nationwide across the United States.
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