Arrow International Recalls Multi Lumen Central Venous Catheterization Kits
Arrow International is recalling 5,926 Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences. The hazard involves a component mismatch in a medical device used for central venous access, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Arrow International Inc is recalling 5,926 units of the Multi Lumen Central Venous Catheterization Kit, Product Code ASK-12703-HH2. The affected units have expiration dates ranging from February 2018 to November 2018 and are identified by Lot number 23F17C0652. The recall was initiated because these finished good kits may contain the incorrect Springwire Guide (SWG).
The recall is classified as Class II by the U.S. Food and Drug Administration. The affected products were distributed nationwide in the United States. The source text does not specify specific hospitals, clinics, or other facilities where the products were distributed.
Healthcare providers and consumers should check their inventory for the specific product code, lot number, and expiration dates listed above. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed by the recall notice.
The recalled product
- Product
- Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 5,926
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 (1)
- Lot number: 23F17C0652
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Arrow International Inc 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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