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Recall Observatory FDA recall evidence

Device product

Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ System and 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.

Z-0779-2019

August 02, 2017

Class II

Product summary

Firm
Haemonetics Corporation
Event
Event 79031
Status
Terminated
Classification
Class II
Quantity
4576 units
Official record key
device-enforcement:Z-0779-2019

Official wording

Reason: Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.

Code information: Catalog number: CSE-P-70

Distribution pattern: US Nationwide Distribution to states of: AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, ME, MN, MO, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.