Serious riskFDA DeviceClass I

Medline convenience kits recalled for possible syringe disconnection

Medline Industries has recalled certain medical convenience kits containing NAMIC angiographic syringes because the syringe adapter may unwind during use. This could cause the syringe to loosen or disconnect from the manifold, potentially compromising the procedure.

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

What to do

  1. Check if you have the affected Medline SKU #DYNJ42892F or DYNJ42892G kits with the listed lot numbers
  2. Stop using the recalled kits immediately
  3. Contact Medline Industries for instructions on return or replacement
  4. Verify lot numbers on your kits against the FDA recall 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: 1. DELIVERY PACK, Medline SKU # DYNJ42892F; 2. DELIVERY PACK, Medline SKU # DYNJ42892G.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 19 products — see all of them.

Details

Units affected
966 kits
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Classification
Class I
Recall number
Z-1727-2026

In the FDA's words

Description
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. DELIVERY PACK, Medline SKU # DYNJ42892F; 2. DELIVERY PACK, Medline SKU # DYNJ42892G. 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 # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 25GMD696; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 25EMJ573; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 25DMC646; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 25BMD630; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24LMA523; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24KMA084; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24JME306; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24FME624; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24EMF099; Medline SKU # DYNJ42892G, UDI/DI each10198459504570, UDI/DI case 40198459504571, Lot Number : 26BMH149; Medline SKU # DYNJ42892G, UDI/DI each10198459504570, UDI/DI case 40198459504571, Lot Number : 26AMD029; Medline SKU # DYNJ42892G, UDI/DI each10198459504570, UDI/DI case 40198459504571, Lot Number : 25KMA060; Medline SKU # DYNJ42892G, UDI/DI each10198459504570, UDI/DI case 40198459504571, Lot Number : 25IMA514. 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: 966 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.

More from Medline

See all

Related topics