Medline special procedure trays recalled over syringe adaptor disconnection risk
Medline is recalling Special Procedure Trays containing NAMIC rotating adaptor control syringes because the adaptor can unwind during use and disconnect from the manifold. 762 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 SPECIAL PROCEDURE TRAY, Medline SKU DYNJ80513B, lot numbers 26ABH752, 25LBL571, 25KBO421, 25IBF501, 25HBL993 and 25FBU283. The action covers 762 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 a number of international markets. The trays are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected trays using the Medline SKU, UDI and lot numbers above, 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: SPECIAL PROCEDURE TRAY, Medline SKU # DYNJ80513B
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Procedure tray
- Affected units
- 762
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 (9)
- Medline SKU # DYNJ80513B
- UDI/DI each 10198459389375
- UDI/DI case 40198459389376
- Lot Numbers: 26ABH752
- 25LBL571
- 25KBO421
- 25IBF501
- 25HBL993
- 25FBU283.
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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