The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0904-2020·Announced 2020-02-05

Haemonetics Recalls Cell Saver Elite Sets Due to Potential Bowl Cracks

Haemonetics is recalling Cell Saver Elite sets because cracks in the bowl core may trap fluid, causing incomplete washing of recovered blood.

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 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 the Japan Cell Saver Elite Set - 225ml. The recall involves 12,370 units distributed worldwide and across all US states. The product is used to recover and process blood shed during or after surgery or trauma for reinfusion into patients.

The recall is due to a potential defect where the inner core of the bowl may develop cracks. This defect can result in fluid being trapped inside the bowl core, which may trigger a long empty device error message and lead to incomplete washing of the processed blood. Specific lots 1118017 and 0718009 are identified as having bowl cracks, while all products manufactured between October 2014 and October 2019 are affected by missing instructions in the instructions for use (IFU) to check for cracks.

Healthcare facilities and users should stop using the affected devices and contact Haemonetics Corporation for further instructions. The recall covers the Japan Cell Saver Elite Set - 225ml with catalog number CSE-P-225-JA.

The recalled product

Product
JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this…
Manufacturer
Haemonetics Corporation
Category
Medical Device — Blood Processing
Hazard
Affected units
12,370

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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