The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0994-2018·Announced 2018-03-21

Arrow Central Venous Catheter Kits Recalled for Missing Identification Stickers

Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.

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, but the specific defect is a missing sticker containing lot and expiration data, which falls under the rubric's criteria for 'documentation issues' and 'minor labeling errors' that do not pose an immediate physical risk of harm.

Plain-English summary

Arrow International Inc is recalling 23,904 Multi-Lumen Central Venous Catheterization Kits with Blue FlexTip Catheter and Sharps Safety Features. The recall is due to a documentation issue where some of the products may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.

The affected products were distributed in the United States in the states of Ohio, Florida, South Carolina, Texas, Kentucky, New Jersey, and Michigan. The specific product codes involved are ASK-12703-PRJ, 13F17B0279, 13F17D0112, ASK-15703-PRJ, and 13F17B0265.

This is an FDA Class II recall. The missing stickers prevent the verification of the product's identity and expiration status, which is a documentation and labeling defect rather than a direct physical hazard to the patient. Healthcare facilities should check their inventory for these specific product codes and contact the manufacturer for further instructions.

The recalled product

Product
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access…
Manufacturer
Arrow International Inc
Category
Medical Device — Catheters
Hazard
Affected units
23,904

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)

  • ASK-12703-PRJ 13F17B0279 13F17D0112 ASK-15703-PRJ 13F17B0265

Distribution

Distributed in 7 states:

Part of a larger recall action

This product is one of 12 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 12 products in this recall →

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