Agency classClass IIOur severity:High FDA (Devices)·Z-1324-2018·Announced 2018-04-18

Arrow International Recalls Central Venous Access Kits Due to Sterility Concerns

Arrow International is recalling specific lots of Arrowg+ard Blue MAC Two-Lumen Central Venous Access Kits because the catheters may not be completely sealed, compromising 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 cannot be guaranteed, posing a risk of infection. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Arrow International Inc. is recalling certain lots of Arrowg+ard Blue MAC Two-Lumen Central Venous Access Kits and Arrowg+ard Blue PSI Kits. The recall involves specific product numbers including ASK-21142-RH, ASK-21242-MMC1, ASK-21242-UCD, CDC-21242-1A, CDC-29803-1A, and CDC-29903-1A.

The recall is being conducted because certain lots of cardiovascular catheters 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, the District of Columbia, and in the Bahamas, Canada, Mexico, Panama, and Singapore.

Healthcare providers and consumers should check their inventory for the specific lot numbers listed in the recall notice. If the product matches the recalled lot numbers, it should be removed from use and returned to the manufacturer or distributor for replacement or refund.

The recalled product

Product: (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5 Fr. Catheters, Product Number: ASK-21242-MMC1; (3)…
Manufacturer: Arrow International Inc
Category: Medical Device — Catheters
Hazard: infection
sterility-compromise

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 (20)

Lot Numbers: (1) 13F16L0254
13F17B0196
13F17C0046
(2) 13F17D0212
13F17E0770
13F17F0438
(3) 13F17E0656
13F17F0188
13F17F0459
(4) 13F17B0139
13F17B0140
13F17B0141
13F17B0142
13F17D0131
13F17D0141
13F17E0509
13F17E0510
13F17E0867
13F17F0439
(5) 13F17C0339

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
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Severe
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Severe
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
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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
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Same hazard · infection