The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0885-2020·Announced 2020-02-05

Haemonetics Recalls CS5/5+ Fastpacks Due to Potential Bowl Cracks

Haemonetics is recalling CS5/5+ Fastpacks because cracks in the bowl core may trap fluid, causing device errors 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 is classified as FDA Class II. The hazard involves a risk of harm (incomplete washing of a medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Haemonetics Corporation is recalling CS5/5+ Fastpacks, 225 mL, 150° Res Autotransfusion Devices. The recall involves 44,821 units distributed worldwide and across all US states. The specific issue involves potential cracks in the inner core of the bowl sets for Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml devices.

The cracks may result in fluid being trapped inside the bowl core. This condition can cause a 'long empty device' error message and the possibility of incomplete washing of the device. The recall covers specific lots 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).

Healthcare facilities and users should stop using the affected devices and contact Haemonetics Corporation for further instructions. The affected catalog number is 00260-00. Specific lot numbers with identified bowl cracks include 1907006HTT, 1902005HTT, 1902008HTT, 1902011HTT, 1906005HTT, 1803013HTT, 1804004HTT, 1804006HTT, 1804002HTT, 1804009HTT, 1805002HTT, 1805003HTT, 1811002HTT, 1812010HTT, 812011HTT, 1901001HTT, 1812005HTT, 1812008HTT, 1901007HTT, 1808006HTT, and 1808010HTT.

The recalled product

Product
CS5/5+ Fastpacks, 225 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 Device
Hazard
Affected units
44,821

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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