NAMIC syringe recall reaches 2.6 million units over adaptor unwinding defect
Medline is recalling a further tranche of NAMIC Angiographic Syringes because the rotating adaptor can unwind during use and disconnect from the manifold. 2,630,369 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 further NAMIC Angiographic Syringes across multiple sizes and configurations, including Medline SKUs 70075027, 70085007, 70085107 and 70087007 as listed in the recall notice. The action covers 2,630,369 units, the largest single record in this series.
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.
The recalled product
- Product
- NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5.
- Manufacturer
- Medline Industries, LP
- Affected units
- 2,630,369
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 70075027
- UDI/DI each 10193489065831
- UDI/DI case 30193489065835
- Lot Numbers: 0000077215
- 0000079109
- 0000082289
- 0000084363
- 0000090369
- 0000107045
- 0000114900
- 0000120770
- 0000122275
- 0000125531
- 0000125834
- 0000132127
- 0000132132
- 0000135020
- 0000135023
- 0000137279
- 0000141698
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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