Arrow International Recalls Central Venous Catheterization Kits with Incorrect Guide
Arrow International is recalling 5,926 Central Venous Catheterization Kits with Blue FlexTip Catheters 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 typically corresponds to a reasonable probability of temporary or medically reversible adverse health consequences. The rubric assigns a score of 3 (High) to risk-of-harm products where injury has not yet been reported, as no specific injuries or illnesses are mentioned in the source text.
Plain-English summary
Arrow International Inc is recalling 5,926 Central Venous Catheterization Kits with Blue FlexTip Catheters (Product code: AK-04301). The affected units have expiration dates ranging from February 2018 to November 2018 and are identified by Lot number 13F17C0501. The recall was initiated because these finished good kits may contain the incorrect Springwire Guide (SWG).
The affected products were distributed nationwide in the United States. The source text does not specify the exact number of units distributed to specific facilities or the specific clinical consequences of using the incorrect guide.
Healthcare facilities and consumers should stop using the affected kits and contact Arrow International Inc for further instructions or a return. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- 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: 13F17C0501
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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