Medline Convenience Kits with Colored Syringes Recalled for Unapproved Design Changes
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 products distributed worldwide including the US, Canada, Panama, and Barbados.
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 is an FDA Class II medical device recall involving syringes used in critical cardiovascular and interventional procedures. Class II recalls can result in serious injury or death, and the unapproved design changes to sterile medical devices pose a significant risk of harm even without reported illnesses.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes. The affected kits include multiple product lines such as TAVR PACK, ABDOMINAL VASCULAR-LF, ANGIOGRAPHIC PACK, AORTAGRAM PACK, and numerous other specialty packs used in medical procedures.
The reason for this recall is that unapproved design changes were made to these products outside of the 510(k) clearance. The affected kits have been distributed worldwide, including nationwide in the United States and in Canada, Panama, and Barbados. A total of 270,311 units have been recalled.
Specific lot numbers and UDI codes for each affected product SKU are available from the FDA. Customers who have received these products should contact Medline Industries, LP for instructions on return or replacement. Healthcare facilities should verify their inventory against the affected lot numbers and SKUs listed in the FDA recall notice.
The recalled product
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF DYNJ905291D ANGIOGRAPHIC PACK DYNJ86769 AORTAGRAM PACK DYNJ26783D AV FISTULA PACK CHS-LF DYNJ35615G AV SHUNT PACK-LF DYNJ0842516
- 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 (6)
- DYNJ47645C Lots 23CMB852 23DMB824 23FMB662 25AMC532
- DYNJ61411 Lots 21LBN952 22LBD611 23EBB430
- DYNJ61411B Lots 25ABI638
- DYNJ65925D Lots 23KLA302 24FLA113 24HLA304 24KLA472 25BLA348 25DLA829
- DYNJ80160 Lots 24ABN644
- DYNJ907758D Lots 23CBO746
Distribution
Distributed nationwide across the United States.