Medline TAVR procedure packs recalled over syringe adaptor disconnection risk
Medline is recalling TAVR PACK convenience kits containing NAMIC rotating adaptor control syringes because the adaptor can unwind during use and disconnect from the manifold. 108 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 the TAVR PACK, Medline SKU DYNJ84472. The action covers 108 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: TAVR PACK, Medline SKU # DYNJ84472
- Manufacturer
- Medline Industries, LP
- Affected units
- 108
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 (7)
- Medline SKU # DYNJ84472
- UDI/DI each 10195327369286
- UDI/DI case 40195327369287
- Lot Numbers: 23LBN016
- 23KBL255
- 23HBL885
- 23FBV799.
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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