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Serious riskFDA DeviceClass I

Medline procedure kits recalled for Namic syringe disconnection risk

Medline has recalled three medical convenience kits containing NAMIC Angiographic Rotating Adaptor syringes used in surgical procedures. The syringe adapter may unwind during use, causing the syringe to disconnect from the manifold and potentially disrupting the procedure.

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

What to do

  1. If your facility has Medline SKU #DYNJ63021B, DYNJ64297B, or DYNJ82411, stop using them immediately
  2. Check lot numbers: 26AMD887, 26AMA970, or 25IMB049
  3. Contact Medline for instructions on how to return or dispose of affected kits
  4. Notify your surgical or procedural team that these kits are no longer safe to use
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: 1. LAPAROSCOPIC HERNIORRHAPHY DSC, Medline SKU # DYNJ63021B; 2. LAP PACK, Medline SKU # DYNJ64297B; 3. MINOR PROCEDURE PACK, Medline SKU # DYNJ82411.
Sold in
Nationwide
Made for
All ages

This recall covers 19 products — see all of them.

Details

Units affected
20 kits
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Classification
Class I
Recall number
Z-1722-2026

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. LAPAROSCOPIC HERNIORRHAPHY DSC, Medline SKU # DYNJ63021B; 2. LAP PACK, Medline SKU # DYNJ64297B; 3. MINOR PROCEDURE PACK, Medline SKU # DYNJ82411. 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 # DYNJ63021B, UDI/DI each 10193489833775UDI/DI case 40193489833776, Lot Number: 26AMD887; Medline SKU # DYNJ64297B, UDI/DI each 10198459472992UDI/DI case 40198459472993, Lot Number: 26AMA970; Medline SKU # DYNJ82411, UDI/DI each 10195327193232UDI/DI case 40195327193233, Lot Number: 25IMB049. 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: 20 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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