Medline Industries Polycarbonate Syringes Convenience Kits Design Change Recall
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. Affected kits were distributed nationwide and internationally.
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: This is an FDA Class II recall of medical devices with unapproved design changes. Although no reported illnesses or injuries are stated in the source text, the hazard involves regulatory deviation (design changes outside cleared specifications) in devices used in critical neurological and vascular procedures, presenting a risk of harm where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 113,843 convenience kits containing select SKUs of 10mL polycarbonate colored syringes. The recalled kits include multiple product types, such as Angiography Packs, Deep Brain Stimulation Packs, Neuro Accessory Packs, Neuro Angio Packs, Neuro Cervical Packs, Neuro Packs, Neuro Trays, Neuro Vascular Packs, Neuro VP Shunt Packs, Neurological Cath Packs, Neuroradiology Packs, Radiology Angio Major Packs, Radiology Neuro Drape Packs, and RRMC Angio Packs.
The firm identified unapproved design changes to the products that were made outside of the FDA 510(k) clearance. These design changes were not part of the original FDA regulatory submission.
The kits were distributed nationwide throughout the United States, including to 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 to the country of Barbados.
Consumers and healthcare facilities in possession of the recalled kits should stop using the affected products and contact Medline Industries for instructions on return or disposal.
The recalled product
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAPHY PACK-LF DYNJ0854485S DEEP BRAIN STIMULATION PACK DYNJ0842793G NEURO ACCESSORY PACK DYNJ55385A NEURO ANGIO PACK DYNJ51697B DYNJ56509G DYNJ56509I DYNJ680
- Manufacturer
- Medline Industries, LP
- Hazard
- unapproved-design-change
- regulatory-deviation
Distribution
Distributed nationwide across the United States.
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