NAMIC angiographic control syringes recalled over rotating adaptor unwinding
Medline is recalling NAMIC Angiographic Control Syringes because the rotating adaptor can unwind during use, causing a loose connection or full disconnection from the manifold. 192,690 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 NAMIC Angiographic Control Syringes, sold under Medline SKUs including 70083007, 70084007, 70084017 and others listed in the recall notice. The action covers 192,690 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 syringes are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the Medline SKU, UDI and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Medline. This is the largest of several related actions covering the same defect in standalone syringes and in convenience kits that contain them.
The recalled product
- Product
- NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/FR,RA,NO,RES,-,P/G, Medline SKU 70084017; 4. SYRINGE,7,ML,TR/FR,RA,W/RES,OE
- Manufacturer
- Medline Industries, LP
- Affected units
- 192,690
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)
- 1. Medline SKU 70083007
- UDI/DI each 10193489065855
- UDI/DI case 30193489065859
- Lot Numbers: 0000077029
- 0000081537
- 0000084335
- 0000087347
- 0000089563
- 0000113792
- 0000115753
- 0000122956
- 0000127785
- 0000131986
- 0000158748
- 0000175535
- 0000187926
- 2. Medline SKU 70084007
- UDI/DI each 10193489065893
- UDI/DI case 30193489065897
- Lot numbers: 0000078186
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.
See all 19 products in this recall →Related recalls
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