Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor...
Reason for Recall / 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.
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98598 |
| Address 1 | 3 Lakes Dr |
| Code info | 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. |
| Postal code | 60093-2753 |
| Report date | 20260415 |
| Product type | Devices |
| Product quantity | 2980 kits |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260227 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260407 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass I
- DistributionWorldwide 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).