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Serious riskFDA DeviceClass I

Medline convenience kits recalled for potential syringe disconnection

Medline has recalled medical convenience kits containing NAMIC Angiographic Rotating Adaptor (RA) syringes because the syringe connector may unwind during use. This can cause a loose or complete disconnection between the syringe and the manifold, potentially interrupting medical procedures.

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

What to do

  1. Stop using the affected Medline medical kits right away
  2. Check your kits against the lot numbers: 25HBV397, 25CBU222, 26BBC195, 26ABI611, 25LBK402, 25KBH371, 25IBK975, and 25HBQ426
  3. Contact Medline or your supplier for replacement kits or instructions
  4. Do not use these syringes on patients
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. NON VASCULAR PACK, Medline SKU # DYNJ68037C; 2. VEIN, Medline SKU # DYNJ89845; 3. VEIN, Medline SKU # DYNJ89845A.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 19 products — see all of them.

Details

Units affected
2980 kits
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Classification
Class I
Recall number
Z-1719-2026

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. NON VASCULAR PACK, Medline SKU # DYNJ68037C; 2. VEIN, Medline SKU # DYNJ89845; 3. VEIN, Medline SKU # DYNJ89845A. 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 # DYNJ68037C, UDI/DI each 10198459239328, UDI/DI case 40198459239329, Lot Number: 25HBV397; Medline SKU # DYNJ89845, UDI/DI each 10198459292460, UDI/DI case 40198459292461, Lot Number: 25CBU222; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 26BBC195; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 26ABI611; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 25LBK402; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 25KBH371; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 25IBK975; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 25HBQ426. 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: 2980 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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