The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0899-2020·Announced 2020-02-05

Haemonetics Recalls Japan Disp Sets Due to Potential Bowl Cracks

Haemonetics is recalling specific Japan Disp Sets for Cell Saver systems due to potential bowl cracks that may cause leaks and incomplete blood washing.

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 3/5 (High).

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 involves a medical device defect (bowl cracks) that could lead to incomplete washing of blood products, posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Haemonetics Corporation is recalling specific Japan Disp Sets (catalog number 261J-SET) used with Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl systems. The recall involves 25,529 units distributed worldwide, including across the United States and various international markets.

The recall is issued because the bowl sets have the potential to develop cracks in the inner core. These cracks can cause leaks that trap fluid inside the bowl core, leading to a 'long empty device' error message and the possibility of incomplete washing of the recovered blood. Additionally, some products manufactured between October 2014 and October 2019 are missing instructions in the Instructions for Use (IFU) to check for cracks.

Healthcare facilities and users of these devices should stop using the affected Japan Disp Sets immediately. Users should check their inventory for the specific lot numbers listed in the recall notice or products manufactured between October 2014 and October 2019. Affected units should be returned to Haemonetics Corporation for replacement or refund.

The recalled product

Product
JAPAN DISP SET, 261J, 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. The recovered blood is processed by a centrifugation and washing…
Manufacturer
Haemonetics Corporation
Category
Medical Device — Blood Processing
Hazard
Affected units
25,529

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 (6)

  • 1118011-0119030-190125H1
  • 1118011-1118031-181226H1
  • 1118011-1118032-181226H1
  • 1118011-1118081-190124H1
  • 1118011-1118082-190124H1
  • 1118011-1118082-190124H2

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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