Medline Convenience Kits with 10mL Syringes Recalled for Unapproved Design
Medline Industries is recalling certain convenience kits containing 10mL polycarbonate colored syringes because of unapproved design changes made outside of FDA 510(k) clearance. The affected kits were distributed nationwide and to Canada, Panama, and Barbados.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving an unapproved design change. The source text does not report any illnesses, injuries, or known adverse events, and the hazard is procedural/regulatory rather than related to product malfunction or contamination.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes. The affected kits include ANGIO KIT PACK, ANGIO PHC, C.I.C.N. ANGIO PACK, FHT P NEURO PACK, NEURO ARTERIOGRAM PACK-LF, NEURO KIT, NEURO PACK, NEURO RADIOLOGY PACK, NEURO TRAY, PK CATH LAB-ANGIO, and QVH IR NEURO PACK, with a total of 270,311 units affected.
The recall was initiated because of unapproved design changes to the products outside of the 510(k) clearance.
The affected kits were distributed worldwide, including the United States (nationwide), Canada, Panama, and Barbados. Specific lot numbers and UDI codes are identified in the FDA recall notice. Customers who have received affected kits should follow instructions provided by Medline Industries regarding the proper handling and return of these products.
The recalled product
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO PHC DYNJ37485C C.I.C.N. ANGIO PACK DYNJ53064B FHT P NEURO PACK DYNJ39931D NEURO ARTERIOGRAM PACK-LF DYNJ0948060F NEURO KIT NAM0003
- Manufacturer
- Medline Industries, LP
- Hazard
- unapproved-design-change
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 (2)
- DYNJ44027F lots 21BLA158 21CLA034 21DLA700 25EBE984 25EBU842
- DYNJ84872A lots 23IBS046
Distribution
Distributed nationwide across the United States.
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