Serious riskFDA DeviceClass I

Medline kits with NAMIC syringes recalled for potential disconnection

Medline has recalled specific batches of medical convenience kits used in robotic procedures because the syringe rotating adaptor may unwind during use. This can cause the syringe to loosen or fully disconnect from the manifold, potentially affecting the procedure. No injuries have been reported.

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

What to do

  1. Check your kit SKU number: DYNJ58475F or DYNJ60803J
  2. Verify the lot number matches the affected batches listed in the recall
  3. Stop using affected kits immediately and isolate them
  4. Contact Medline or your hospital supply department for replacement instructions

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. ROBOTIC PACK, Medline SKU # DYNJ58475F; 2. URO/GEN ROBOTIC PACK, Medline SKU # DYNJ60803J.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 19 products — see all of them.

Details

Units affected
439 kits
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Classification
Class I
Recall number
Z-1728-2026

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. ROBOTIC PACK, Medline SKU # DYNJ58475F; 2. URO/GEN ROBOTIC PACK, Medline SKU # DYNJ60803J. 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 # DYNJ58475F, UDI/DI each 10198459572388, UDI/DI case 40198459572389, Lot Number: 25LMK173; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 26BMA268; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 26AMH928; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25EMD876; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25EMA519; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25DMA846; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25BMH004; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25BMA218; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24KMI208; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24KMC007; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24JMD850; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24IMI939; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24EDB694; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24DDB793; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24CDB207; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24BDB439; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 23GDB756; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 23GDA532. 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: 439 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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