The Recall Desk
HighFDA (Devices)·Z-0905-2020·Announced 2020-02-05

Haemonetics Recalls Cell Saver Bowl Sets Due to Leak Risk

Haemonetics is recalling specific Cell Saver bowl sets because they may leak, potentially trapping fluid and causing 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 blood processing equipment) without reported injuries or illnesses, fitting the 'High' severity criteria.

Plain-English summary

Haemonetics Corporation is recalling specific lots of Japan DISP SET, 263J, 205J, and 208 bowl sets used with Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml systems. These components are intended for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.

The recall is due to a potential for leaks at the inner core of the bowl sets. This defect could result in fluid being trapped inside the bowl core, which may cause a long empty device error message and the possibility of incomplete washing. The recall covers 14,271 units distributed worldwide, including the United States and various international locations.

Users should stop using the affected bowl sets immediately. The specific lots affected include those with 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 recalled product

Product
Japan DISP SET, 263J, 205J, 208 - 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 Equipment
Hazard
Affected units
14,271

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 (10)

  • 0718027-0119029-190125H1
  • 0718027-0818085-181030H1
  • 0718027-0818086-181030H1
  • 0718027-1018006-181224H1
  • 0718027-1018007-181224H1
  • 0718027-1018008-181225H1
  • 0718027-1018009-181226H1
  • 0718027-1118031-181226H1
  • 0718027-1118032-181226H1
  • 0718027-1118081-190124H1

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 →

Related recalls

Same manufacturer · Haemonetics Corporation

See all →

Same hazard · leak

See all →