Medline cath lab packs recalled over syringe rotating adaptor disconnection
Medline is recalling cath lab and angiography procedure packs containing NAMIC rotating adaptor control syringes because the adaptor can unwind and disconnect. 17,902 kits 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 packs including CATH LAB PACK-LF (SKU 00-HCT055P), INTERVENTIONAL CATH LAB PK-LF (SKU DYNJ0376230Q) and ANGIOGRAPHY CATH LAB, with the full list in the recall notice. The action covers 17,902 kits.
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: 1. CATH LAB PACK-LF, Medline SKU 00-HCT055P; 2. INTERVENTIONAL CATH LAB PK-LF, Medline SKU DYNJ0376230Q; 3. ANGIOGRAPHY CATH LAB,
- Manufacturer
- Medline Industries, LP
- Affected units
- 17,902
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 00-HCT055P
- UDI/DI each 10193489297393
- UDI/DI case 40193489297394
- Lot Number 24BBI341
- Lot Number 23LBP066
- Lot Number 23KBS305
- Lot Number 23JBA062
- Lot Number 23HBR594
- Lot Number 23DBR051
- Medline SKU DYNJ0376230Q
- UDI/DI each 10193489759303
- UDI/DI case 40193489759304
- Lot Number 24ABO014
- Lot Number 23KBW878
- Lot Number 23HBP761
- Lot Number 23FBW006
- Lot Number 23DBF403
- Medline SKU DYNJ23532C
- UDI/DI each 10193489460872
- UDI/DI case 40193489460873
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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