The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0896-2020·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 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 with a 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 CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device. The recall involves 14,698 units distributed worldwide and across all 50 US states, DC, and several international countries. The devices 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 Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. These leaks could result in fluid being trapped inside the bowl core, causing a long empty device error message and the possibility of incomplete washing. Specific lots with bowl cracks (1902003HTT, 1902002HTT, 1909003HTT) were distributed, and all products manufactured between October 2014 and October 2019 are missing instructions to check for cracks in the Instructions for Use (IFU).

Healthcare facilities and users should stop using the affected devices and contact Haemonetics Corporation for further instructions on returns or replacements.

The recalled product

Product
CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - 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 — Autotransfusion
Hazard
Affected units
14,698

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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