Medline cardiac catheterization kits recalled over syringe adaptor unwinding
Medline is recalling right and left heart catheterization and angiography kits containing NAMIC rotating adaptor control syringes because the adaptor can unwind and disconnect. 79,843 units are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.
Plain-English summary
Medline Industries, LP is recalling medical convenience kits containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes. This action covers kits including the MTS RH LFT HRT KIT (SKU 60010508), MTS 3V W/GUIDE (SKU 60100701), ANGIOGRAPHY KIT (SKU 60131209) and MTS LHK, with the full list in the recall notice. The action covers 79,843 units.
Medline 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 the manifold. The FDA classified the action as Class I, its most serious classification.
Distribution was worldwide, covering the United States nationwide including Puerto Rico, and Canada, the Netherlands, Australia, the Republic of Korea, Sri Lanka, Pakistan, Japan, the United Arab Emirates, Singapore and Slovakia. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected kits using the Medline SKU, UDI and lot numbers in the recall notice, quarantine any stock on hand, and follow the instructions issued by Medline.
The recalled product
- Product
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. MTS RH LFT HRT KIT, Medline SKU # 60010508; 2. MTS 3V W/GUIDE, Medline SKU # 60100701; 3. ANGIOGRAPHY KIT, Medline SKU # 60131
- Manufacturer
- Medline Industries, LP
- Affected units
- 79,843
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Medline SKU # 60010508
- UDI/DI each 10193489040340
- UDI/DI case 40193489040341
- Lot Number: 26BBI625
- Lot Number: 26ABB718
- Lot Number: 25JBJ140
- Lot Number: 25HBF702
- Lot Number: 25GBC747
- Lot Number: 25DBR341
- Lot Number: 25CBK686
- Lot Number: 25ABR102
- Lot Number: 24IBK765
- Lot Number: 24GBS605
- Lot Number: 24EBO156
- Lot Number: 24BBG055
- Lot Number: 24ABH036
- Lot Number: 23LBI829
- Lot Number: 23KBN009
- Lot Number: 23FBO996
- Lot Number: 23FBA259
Distribution
Part of a larger recall action
This product is one of 19 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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