The Recall Desk
HighFDA (Devices)·Z-0906-2020·Announced 2020-02-05

Haemonetics Recalls Japan DISP SETs Due to Potential Bowl Cracks

Haemonetics is recalling 1,584 Japan DISP SETs because cracks in the bowl core may cause leaks and incomplete washing.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (incomplete washing of a medical device) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Haemonetics Corporation is recalling 1,584 units of the Japan DISP SET (catalog numbers 263J, 205J, HAR) due to a defect in the bowl core. The recall covers specific lots with identified bowl cracks and all products manufactured between October 2014 and October 2019 that are missing instructions to check for cracks in the Instructions for Use (IFU).

The defect involves potential cracks in the inner core of the Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. These cracks can lead to leaks that trap fluid inside the bowl core, resulting in a long empty device error message and the possibility of incomplete washing of the device.

The affected products were distributed worldwide, including nationwide in the United States and in various countries such as New Zealand, Australia, India, Pakistan, the Philippines, and several European nations. Users should stop using the affected sets and contact Haemonetics Corporation for further instructions.

The recalled product

Product
Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma
Manufacturer
Haemonetics Corporation
Category
Medical Device — Blood Processing
Hazard
Affected units
1,584

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 (2)

  • 0718027-0818086-08170711018045
  • 0718027-1118031-08170711118019

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

Part of a larger recall action

This product is one of 22 recalled by Haemonetics Corporation 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 22 products in this recall →

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