The Recall Desk
ModerateFDA (Devices)·Z-2818-2018·Announced 2018-08-22

Arrow Hands-Off Central Venous Catheter Recalled for Packaging Seal Defects

Arrow International Inc. is recalling 7,024 units of Hands-Off Multi-Lumen Central Venous Catheters because packaging may not be sealed, potentially compromising sterility.

What this means for you

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, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a potential sterility breach due to packaging defects, which is a significant risk but does not meet the criteria for Class I (death/serious injury) or Class III (unlikely to cause harm).

Plain-English summary

Arrow International Inc. is recalling 7,024 units of the HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip. This medical device is used with the Arrow One-Piece Percutaneous Sheath Introducer System to provide venous access to the central circulation. The recall is due to a defect where the product packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.

The affected units were distributed nationwide in the United States to the states of AK, AL, CA, FL, HI, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NY, OH, OR, PA, SC, SD, TX, WI, and WV. The products were also distributed to Finland, Germany, Hungary, the Netherlands, South Africa, the United Arab Emirates, and the United Kingdom. The specific lot codes for the recalled units are 14F15F0156, 14F15H0228, 14F15K0746, 14F16B0085, 14F16D0424, 14F16F0700, and 14F16G0471.

Healthcare providers and facilities should check their inventory for these specific lot codes. If the packaging is found to be unsealed or compromised, the product should not be used, as its sterility cannot be guaranteed. Users should contact Arrow International Inc. for further instructions regarding the return or replacement of these units.

The recalled product

Product
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous shea
Manufacturer
Arrow International Inc
Category
Medical Device — Catheters
Hazard
Affected units
7,024

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 (7)

  • 14F15F0156
  • 14F15H0228
  • 14F15K0746
  • 14F16B0085
  • 14F16D0424
  • 14F16F0700
  • 14F16G0471

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Arrow International Inc

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Same hazard · sterility compromise

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