Arrow International Recalls MAC Two-Lumen Central Venous Access Kits
Arrow International Inc is recalling MAC Two-Lumen Central Venous Access Kits because unsealed packaging may compromise product 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 medical device where sterility may be compromised, posing a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Arrow International Inc is recalling 416,055 units of MAC Two-Lumen Central Venous Access Kits with ARROWg+ard Blue Access Devices. The recall involves product codes ASK-21242-NYP and ASK-21242-PR, which are used with 7.5 - 8 Fr. catheters.
The recall is being conducted because product sterility may be compromised due to unsealed packaging. The affected lots are distributed in the United States and numerous international locations, including Australia, Canada, and the United Kingdom.
Healthcare facilities and distributors should stop using the affected products and contact Arrow International Inc for further instructions. Consumers should not use these medical devices if they have been purchased or are in their possession.
The recalled product
- Product
- MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-21242-NYP and ASK-21242-PR
- Manufacturer
- Arrow International Inc
- Affected units
- 416,055
Distribution
Part of a larger recall action
This product is one of 76 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 76 products in this recall →Related recalls
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Similar recalls
- HighArrow International Recalls Central Venous Access Kits Due to Sterility Concerns
FDA (Devices) · 2018-04-18
- ModerateArrow International Recalls Central Venous Access Kits Due to Packaging Seal Issues
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- ModerateArrow International Recalls Two-Lumen Central Venous Access Kits
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- HighArrow MAC Two-Lumen Central Venous Access Kits Recalled for Sterility Concerns
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- SevereArrow International Recalls Central Venous Access Kits Due to Needlestick Risk
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- ModerateArrowgard Blue MAC Central Venous Access Kit recalled for defective adhesive
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