Medline convenience kits recalled for unapproved syringe design changes
Medline Industries recalls convenience kits containing 10mL polycarbonate colored syringes because design changes were made outside of FDA-cleared specifications. The recall affects approximately 113,843 kits distributed nationwide.
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: This is an FDA Class II recall involving medical devices used in critical clinical procedures (vascular access, pacemaker, endovascular). Design changes made outside cleared specifications present a potential for adverse health consequences in the clinical setting, meeting the threshold for Severe classification.
Plain-English summary
Medline Industries, LP is recalling convenience kits containing select 10mL polycarbonate colored syringes used in various clinical applications including abdominal vascular, arteriogram, endovascular, pacemaker, and vascular access procedures. The affected kits include multiple SKUs and lot numbers distributed US nationwide, including all 50 states and Barbados.
The manufacturer identified unapproved design changes to the products that occurred outside of the FDA-cleared 510(k) specifications. These products were not initially reported in FDA recall RES 98601.
Consumers and healthcare facilities that have received these kits should stop use and contact Medline Industries for instructions on return or replacement. Consumers with questions about whether they have affected product should check their packaging against the specific SKU and lot numbers listed in this recall.
The recalled product
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ABDOMINAL VASCULAR-LF DYNJ905291B DYNJ905291C ARTERIOGRAM DYNJ28082G CVICU HEART BAG DYKM2130A ENDOVASCULAR PACK DYNJ0678934J EP PACK DYNJ23456J GENERAL ENDO…
- Manufacturer
- Medline Industries, LP
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.
See all 16 products in this recall →Related recalls
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