Agency classClass IIOur severity:High FDA (Devices)·Z-1323-2018·Announced 2018-04-18

Arrow MAC Two-Lumen Central Venous Access Kits Recalled for Sterility Concerns

Arrow International is recalling specific lots of MAC Two-Lumen Central Venous Access Kits because the seals may be incomplete, preventing a guarantee of sterility.

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 3/5 (High).

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 involves a risk-of-harm product (medical device) where sterility cannot be guaranteed, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Arrow International Inc. is recalling certain lots of MAC Two-Lumen Central Venous Access Kits, including product numbers ASK-11242-PHP and CDC-11242-1A. The recall is being conducted because the cardiovascular catheters in these kits may not be completely sealed. As a result, the sterility of the product cannot be guaranteed.

The affected products were distributed in all 50 U.S. states and the District of Columbia, as well as in the Bahamas, Canada, Mexico, Panama, and Singapore. The specific lot numbers involved are 13F17D0179 for the ASK-11242-PHP product and 13F17B0232, 13F17C0357, 13F17D0312, 13F17E0289, 13F17F0154, 13F17F0327, and 13F17F0614 for the CDC-11242-1A product.

Healthcare facilities and consumers should check their inventory for these specific product numbers and lot numbers. If the products are found, they should be removed from use and returned to the distributor or manufacturer according to the recall instructions.

The recalled product

Product: (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow¿ MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A
Manufacturer: Arrow International Inc
Category: Medical Device — Catheters
Hazard: sterility
infection

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 (8)

(1) Lot Number: 13F17D0179
(2) Lot Numbers: 13F17B0232
13F17C0357
13F17D0312
13F17E0289
13F17F0154
13F17F0327
13F17F0614

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 14 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.

See all 14 products in this recall →

Same manufacturer · Arrow International Inc

See all →

High
Arrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
Severe
Intra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
Severe
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
Severe
Arrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
Severe
ARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27

Same hazard · sterility