FDA-Device2026-04-15Class IPROCESSING DEFECT
Medline TAVR Pack medical kits recalled for syringe adapter disconnection risk
OTHERNationwide distribution
Stop using Medline TAVR Pack kits immediately
Medline medical convenience kits containing NAMIC Angiographic Rotating Adaptor syringes may have a defect where the syringe adapter can unwind during use. This could cause the syringe to loosen or fully disconnect from the manifold during a procedure, potentially affecting patient care.
- Stop using Medline TAVR Pack (SKU # DYNJ84472) immediately if you have it
- Check if your kit matches lot numbers 23LBN016, 23KBL255, 23HBL885, or 23FBV799
- Contact Medline Industries, LP for instructions on returning or replacing affected units
- Verify your medical facility has been notified by your supplier
Hazard
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Sold states
Worldwide distribution: US (nationwide) including Puerto Rico (PR) and OUS (foreign) to countries of: Canada (CA), Netherlands (NL), Australia (AU), Korea, Republic of (KR), Sri Lanka (LK), Pakistan (PK), Japan (JP), United Arab Emirates (AE), Singapore (SG) and Slovakia (SK).
Affected count
108 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: TAVR PACK, Medline SKU # DYNJ84472
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1729-2026More Medline Industries, LP recalls
- FDA-Device2026-06-03Medline EYE TRAY-LF medical kit recalled for mismatched syringes
- FDA-Device2026-06-03Medline spinal anesthesia and nerve block kits recalled for bupivacaine quality and efficacy concerns
- FDA-Device2026-05-20Medline Namic Preceptor blood pressure manifold recalled for particulate contamination
- FDA-Device2026-05-20Medline TAVI medical convenience kits recalled for particulate contamination in fluid path
- FDA-Device2026-05-20Medline medical convenience kits with Namic Manifold recalled for particulate contamination
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