Medline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
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 in 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 involving medical devices with design changes made outside of approved clearance. Class II recalls with manufacturing/design deviations on devices intended for invasive procedures meet the "Severe" criterion, particularly given the range of invasive/surgical applications (neurosurgery, catheterization, interventional radiology).
Plain-English summary
Medline Industries, LP is recalling convenience kits containing select SKUs of 10mL polycarbonate colored syringes used in various medical procedures. The recall includes kits such as arteriogram trays, AV shunt packs, basic interventional radiology packs, catheterization procedure trays, and many others listed with specific product codes and lot numbers.
The firm 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 an earlier FDA recall (RES 98601).
The affected kits were distributed nationwide across 33 U.S. states (AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY) and to Barbados. A total of 113,843 kits are affected.
Consumers and healthcare facilities that have received these kits should stop using them and contact Medline Industries for instructions on return or replacement.
The recalled product
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651B ARTERIOGRAM TRAY 00-402001S AV SHUNT PACK-LF DYNJ0842516F BASIC IR PACK-LF PHS463660F CATH PROCEDURAL TRAY DYNJ43580C CONGENITAL ADD-ON KIT…
- 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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