Medline Convenience Kits containing 10mL Polycarbonate Colored Syringes recalled
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects multiple product SKUs distributed nationwide and internationally.
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 invasive clinical procedures. The hazard stems from unapproved design changes to products that received 510(k) clearance under different specifications, creating a potential risk of harm in high-risk medical settings even though no adverse events are reported in the source.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes. The affected products include multiple tray and pack configurations used in clinical settings, including Arteriogram Trays, Cath Lab-Vein Procedures kits, Central Venous Access Packs, Fistulagram Packs, Invasive Line Insertion kits, Non Vascular Packs, PICC Abscess Packs, PICC Line Packs, and PICC PHC packs. A total of 270,311 units have been distributed worldwide across the United States, Canada, Panama, and Barbados.
The reason for the recall is that unapproved design changes were made to the products outside of the 510(k) clearance granted by the FDA. This means modifications were implemented that had not been reviewed or cleared through the proper regulatory pathway.
Consumers and healthcare facilities that have received these products should stop using affected lots and contact Medline Industries, LP for instructions on return or replacement. Lot numbers and UDI codes for the affected kits are detailed in the recall notice.
The recalled product
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T, 00-402001U CATH LAB-VEIN PROCEDURES DYNJ60329A CENTRAL VENOUS ACCESS PACK-LF CVI5070 FISTULAGRAM PACK DYNJ66259 INVASIVE LINE INSERTION…
- Manufacturer
- Medline Industries, LP
- Affected units
- 270,311
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 (3)
- DYNJ44123C Lots 25BMC026
- DYNJ47717B Lots 23DME176
- DYNJ68037B Lots 23JBM013 23LBR847 24CBM608 24DBQ050 24HBT816 25ABA997
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 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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