Recall Weekly
Serious riskFDA DeviceClass I

Medline TAVR Pack kits recalled for potential syringe disconnection

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.

From the FDA notice · Read the official notice ↗ · All Medline recalls

What to do

  1. Stop using Medline TAVR Pack (SKU # DYNJ84472) immediately if you have it
  2. Check if your kit matches lot numbers 23LBN016, 23KBL255, 23HBL885, or 23FBV799
  3. Contact Medline Industries, LP for instructions on returning or replacing affected units
  4. Verify your medical facility has been notified by your supplier
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: TAVR PACK, Medline SKU # DYNJ84472
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 19 products — see all of them.

Details

Units affected
108 units
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Classification
Class I
Recall number
Z-1729-2026

In the FDA's words

Description
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: TAVR PACK, Medline SKU # DYNJ84472 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. Medline SKU # DYNJ84472, UDI/DI each 10195327369286, UDI/DI case 40195327369287, Lot Numbers: 23LBN016, 23KBL255, 23HBL885, 23FBV799. Distribution: 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 quantity: 108 units
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.

19 products in this recall

Medline NAMIC angiographic syringes recalled for disconnection risk

Medline is recalling 19 NAMIC angiographic syringes and Medline convenience kits that contain them. The syringe's rotating adaptor can unwind during use, which may loosen or fully disconnect the syringe from the manifold. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

More from Medline

See all

Related topics

OtherMedical devicesSold nationwideMore from FDA Device