Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0331-2017·Announced 2016-11-09

Arrow Hands-Off Infusion Port Thermodilution Catheter Recalled for Labeling Inconsistency

Arrow International Inc is recalling specific lots of Hands-Off Infusion Port Thermodilution Catheters due to a labeling inconsistency. The recall covers 330 units in the US and 1,031 units outside the US.

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 is due to a labeling inconsistency, which aligns with the rubric criterion for minor labeling errors or low-risk issues.

Plain-English summary

Arrow International Inc is recalling specific lots of the HANDS-OFF Infusion Port Thermodilution Catheter. This medical device consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield with an integral flushing/balloon test chamber, designed to allow practitioners to prepare, test, and insert the catheter without exposing it to external contamination.

The recall was initiated due to a labeling inconsistency. The affected units were distributed nationwide in the United States and internationally. A total of 330 units were distributed in the US and 1,031 units were distributed outside the US. The affected lot numbers are 16F15C0114, 16F15D0003, 16F15A0072, 16F15F0031, 16F15F0090, 16F15H0037, 16F16B0001, 16F16B0014, 16F16C0056, 16F16C0079, 16F16C0109, 16F16E0004, and 16F16E0030.

Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Users should contact Arrow International Inc for further instructions regarding the return or replacement of these units.

The recalled product

Product: HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, enabling the practitioner to prepare, test, and insert the catheter without…
Manufacturer: Arrow International Inc
Category: Medical Device — Catheter
Hazard: mis-labeling

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 (13)

Lot # 16F15C0114
16F15D0003
16F15A0072
16F15F0031
16F15F0090
16F15H0037
16F16B0001
16F16B0014
16F16C0056
16F16C0079
16F16C0109
16F16E0004
16F16E0030

Distribution

Distributed nationwide across the United States.

Same manufacturer · Arrow International Inc

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