Arrow International Recalls Multi-Lumen Central Venous Catheter Sets
Arrow International is recalling 1,200 multi-lumen central venous catheter sets due to increased resistance during insertion, which may cause procedural delays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves procedural delay and the need for catheter exchange, which constitutes a moderate risk without reports of serious injury or death.
Plain-English summary
Arrow International Inc is recalling 1,200 units of the Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter (Model CS-15853-E). The recall is associated with the code 71F18A0682. These devices are intended to permit venous access to the central circulation through a single puncture site via the femoral, jugular, or subclavian veins.
The recall was initiated after the firm received complaints regarding increased resistance encountered when introducing the catheter over the spring wire guide. This issue may lead to procedural delays and may require medical intervention to exchange the catheter for another central venous catheter.
The affected units were distributed to a distributor in Florida and internationally to the Czech Republic, Dominican Republic, France, Greece, and Italy. Healthcare facilities should stop using the affected lots and contact the manufacturer for instructions on replacement or return.
The recalled product
- Product
- Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single puncture site by way of the femoral, jugular, or subclavian veins.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Affected units
- 1,200
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)
- 71F18A0682
Distribution
Distributed in 1 state:
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