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Serious riskFDA DeviceClass I

Medline procedure trays recalled for possible syringe disconnection

Medline has recalled certain medical convenience kits (SKU # DYNJ80513B) because the syringe rotating adaptor can unwind during use. This may cause the syringe to become loose or fully disconnect from the manifold, potentially affecting medical procedures.

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

What to do

  1. Check if you have the affected kit: Medline SKU # DYNJ80513B with lot numbers 26ABH752, 25LBL571, 25KBO421, 25IBF501, 25HBL993, or 25FBU283
  2. Stop using the kit immediately
  3. Contact Medline Industries for instructions on return or replacement
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: SPECIAL PROCEDURE TRAY, Medline SKU # DYNJ80513B
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 19 products — see all of them.

Details

Units affected
762 units
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Classification
Class I
Recall number
Z-1720-2026

In the FDA's words

Description
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: SPECIAL PROCEDURE TRAY, Medline SKU # DYNJ80513B 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 # DYNJ80513B, UDI/DI each 10198459389375, UDI/DI case 40198459389376, Lot Numbers: 26ABH752, 25LBL571, 25KBO421, 25IBF501, 25HBL993, 25FBU283. 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: 762 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.

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