Additional NAMIC angiographic syringe lots recalled over adaptor unwinding
Medline is recalling a further group of NAMIC Angiographic Syringe lots because the rotating adaptor can unwind during use and disconnect from the manifold. 149,439 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 lots of NAMIC Angiographic Syringes, covering Medline SKUs including 70075027, 70085007, 70085107 and 70087007 as listed in the recall notice. The action covers 149,439 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 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. MTO,SYRING
- Manufacturer
- Medline Industries, LP
- Affected units
- 149,469
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 60010027
- Lot Number 25EBF689
- Lot Number 25CBL960
- Lot Number 24LBO743
- Medline SKU 60010195
- Lot Number 25ABI082
- Lot Number 24IBJ827
- Lot Number 24HBO437
- Lot Number 24DBR149
- Lot Number 24CBF820
- Medline SKU 60011433
- Lot Number 26BBJ156
- Lot Number 26ABH642
- Lot Number 25KBJ356
- Lot Number 25HBQ865
- Lot Number 25FBS131
- Lot Number 25DBR246
- Lot Number 25CBS392
- Lot Number 25CBB739
- Lot Number 24JBR628
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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