Agency classClass IIOur severity:High FDA (Devices)·Z-1331-2018·Announced 2018-04-18

Arrow International Recalls Certain Central Venous Catheterization Kits

Arrow International is recalling specific lots of central venous and vessel catheterization kits because the seals may be incomplete, potentially 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 is classified as FDA Class II. The hazard involves a risk of harm (infection due to compromised sterility) in a medical device, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Arrow International Inc is recalling certain lots of Central Venous Catheterization Kits, Single-Lumen Central Venous Catheterization Kits with Blue FlexTip Catheters, and Vessel Catheterization Kits. The recall involves specific part numbers and lot numbers identified in the agency's records.

The recall was initiated because the cardiovascular catheters may not be completely sealed. As a result, the sterility of the product cannot be guaranteed. This defect poses a risk of infection if the non-sterile product is used in a clinical setting.

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 facilities should check their inventory for the specific lot numbers listed in the recall notice and stop using any affected units. Consumers should contact their healthcare provider if they have had a procedure using these specific products.

The recalled product

Product: (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) Vessel Catheterization Kit, PN: ASK-04550-NYP
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 (8)

Lot Numbers: (1) 13F17D0048
(2) 13F17E0659
(3) 13F17A0075
13F17C0503
13F17D0296
13F17E0541
13F17F0220
13F17G0002

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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Arrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
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Same hazard · infection