The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0894-2020·Announced 2020-02-05

Haemonetics Recalls CS Elite Fastpack Autotransfusion Devices Due to Leak Risk

Haemonetics is recalling CS Elite Fastpack autotransfusion devices because cracks in the bowl core 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 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 1,092 units of the CS Elite Fastpack, 225 mL, 20° Res Autotransfusion Device. The recall covers specific lots with bowl cracks (1901003HTT and 1810008HTT) 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 recall is due to a potential for leaks at the inner core of the device's bowl sets. This defect could result in fluid being trapped inside the bowl core, causing a long empty device error message and the possibility of incomplete washing of the blood product.

The affected devices were distributed worldwide, including nationwide in the United States and in various countries in Asia, Europe, and Oceania. The devices are intended for use in recovering and processing blood shed during or after surgery or trauma for reinfusion into the patient. Users should stop using the affected devices and contact Haemonetics Corporation for further instructions.

The recalled product

Product
CS Elite Fastpack, 225 mL, 20¿ Res Autotransfusion Device - 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…
Manufacturer
Haemonetics Corporation
Category
Medical Device — Blood Processing
Hazard
Affected units
1,092

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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