The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0995-2018·Announced 2018-03-21

Arrow Central Venous Catheter Kits Recalled for Missing Label Information

Arrow International is recalling 23,904 central venous catheter kits because some units may be missing stickers with lot, expiration, 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 and involves a labeling defect (missing stickers) rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Arrow International Inc is recalling 23,904 Pressure Injectable Multi-Lumen Central Venous Catheterization Kits with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, and Sharps Safety Features. The recall is due to the possibility that some of the products are missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.

The affected products are indicated for short-term central venous access. The recall covers units distributed in the United States in the states of Ohio, Florida, South Carolina, Texas, Kentucky, New Jersey, and Michigan. Specific lot codes associated with the recall include ASK-42703-PRJ, 13F16L0007, 13F16M0013, 13F17A0296, 13F17D0110, and 13F17F0319.

Healthcare facilities and consumers should check their inventory for these specific product codes and verify that the required labeling stickers are present. If a unit is missing the sticker with lot, expiration, and UDI information, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(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…
Manufacturer
Arrow International Inc
Category
Medical Device — Central Venous Catheter
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-42703-PRJ 13F16L0007 13F16M0013 13F17A0296 13F17D0110 13F17F0319

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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