Medline Convenience Kits with 10mL Polycarbonate Colored Syringes Recalled
Medline Industries is recalling multiple convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed in the US and internationally.
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: This recall is classified by FDA as Class II and involves medical devices that are used in high-risk clinical procedures (cardiac catheterization, neuro procedures, vascular access). Unapproved design changes outside of 510(k) clearance represent a significant regulatory violation that could affect device safety and effectiveness, meeting the Severe criteria for FDA Class II recalls involving medical devices used in critical procedures.
Plain-English summary
Medline Industries, LP is recalling multiple Medline Convenience Kits that contain select SKUs of 10mL polycarbonate colored syringes. The recall includes approximately 270,311 units across numerous kit types, including angiography packs, cardiac catheterization packs, neuro procedure packs, and vascular access kits.
The product is being recalled because unapproved design changes were made to the products outside of the scope of the FDA 510(k) clearance. This means modifications were implemented without the required FDA review and approval process.
The affected kits have been distributed worldwide, including throughout the United States and to the countries of Canada, Panama, and Barbados. Multiple lot numbers across numerous product SKUs are affected; specific affected lot numbers and UDI codes are listed in the FDA recall notice.
Customers who have received affected products should contact Medline Industries for instructions regarding the recalled items. The affected products should not be used until proper guidance is obtained from the manufacturer.
The recalled product
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDOVASCULAR PACK-LF DYNJ0429339L, DYNJ0429339M ANGIO ARTERIOGRAM PACK-LF DYNJ0774026K ANGIO KIT PACK DYNJ83746B ANGIO TRAY NO LIDO DYNJ85557A ANGIOGRAPHY PACK II DYNJ1
- 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 (20)
- DYNJ0429121M lots 24GME309 25AMA768 25AMI616 25CMC127 25DME972 25EMH823
- DYNJ0429339M lots 25AMI338 25BMI962 25DMG132
- DYNJ0774005I lots 25ABU445 25EBJ726
- DYNJ0774026K lots 25ABL910 25CBC859
- DYNJ0842478M lots 25BMD033
- DYNJ0842499L lots 25ADA394 25ADB067 25BDB213
- DYNJ0842873L lots 25AMF044 25BMI157 25CMJ723
- DYNJ0843063M lots 24KDA944 25BMC710 25CMB746
- DYNJ0843121L lots 25BMA139 25BMG893
- DYNJ0843339P lots 25AMC387 25BMI894
- DYNJ30551J lots 25BLA948 25DLA390 25ELA675 25FLA636
- DYNJ30554I lots 25BLB061 25CLA785 25FLA348
- DYNJ36338D lots 25AMD997 25DMB069 25EMA091
- DYNJ50779G lots 25BMC031 25BMF563 25CMI786 25DMH709
- DYNJ51423G lots 25DLB019
- DYNJ56386D lots 25BBK025 25DBL564
- DYNJ57543K lots 25BMA534 25BMH775 25DMA332
- DYNJ61373B lots 25BBD697 25CBH388 25EBE177
- DYNJ62745A lots 24EBG787 24FBM384 24GBE754 24GBY096 24HBM688
- DYNJ62747A lots 24LBU340 25ABC752 25CBD229 25DBH729
Distribution
Distributed nationwide across the United States.