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Serious riskFDA DeviceClass I

Medline medical kits recalled for possible syringe disconnection risk

Medline medical convenience kits containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes may have a defective rotating adaptor that can unwind during use. This could cause the syringe to disconnect from the manifold during a medical procedure. The issue affects 60 kits distributed in the US and 10 other countries.

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

What to do

  1. Stop using medical convenience kits with SKU # DYNJ86596, particularly Lot Numbers 24FMI029 or 24DMK138
  2. Check if your facility received this kit and set it aside
  3. Contact Medline Industries or your healthcare provider for replacement instructions
  4. Report any disconnections or injuries to Medline or the FDA
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: MINOR PLASTIC-LF, Medline Kit SKU # DYNJ86596
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 19 products — see all of them.

Details

Units affected
60 kits
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Classification
Class I
Recall number
Z-1723-2026

In the FDA's words

Description
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: MINOR PLASTIC-LF, Medline Kit SKU # DYNJ86596 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 Kit SKU # DYNJ86596, UDI/DI each 10195327656119, UDI/DI case 40195327656110, Lot Numbers: 24FMI029, 24DMK138. 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: 60 kits
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.

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