Agency classClass IIOur severity:Low FDA (Devices)·Z-1000-2018·Announced 2018-03-21

Arrow International Recalls Central Venous Access Kits Due to Missing Labels

Arrow International is recalling 23,904 central venous access kits because some units 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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is for a documentation and packaging issue (missing stickers) with no reported injuries or illnesses, fitting the 'Low' severity criteria for cosmetic or documentation defects.

Plain-English summary

Arrow International Inc. is recalling 23,904 units of the ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The recall is being conducted because 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 to the states of Ohio, Florida, South Carolina, Texas, Kentucky, New Jersey, and Michigan. The specific product codes associated with this recall are CDA-21242-1A, 13F16L0209, and 13F17F0437.

Healthcare providers and facilities 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 the lot number, expiration date, or UDI, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product: ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit 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 including, but not limited to: multiple…
Manufacturer: Arrow International Inc
Category: Medical Device — Central Venous Access
Hazard: mis-labeling
documentation-error
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)

CDA-21242-1A 13F16L0209 13F17F0437

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 →

Same manufacturer · Arrow International Inc

See all →

High
Arrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
Severe
Intra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
Severe
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
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
FDA (Devices) · 2024-03-27

Same hazard · mis labeling