Haemonetics Recalls Cell Saver Elite Processing Kits Due to Leakage Risk
Haemonetics is recalling 4,576 Cell Saver Elite Processing Kits because the 70ml centrifuge bowl may leak during cell salvage processing.
What this means for you
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 functional defect (leakage) that poses a risk of harm during a medical procedure, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Haemonetics Corporation is recalling 4,576 units of the Cell Saver Elite Processing Kit, 70 ml (Product ID: CSE-P-70). The recall was initiated after the company received isolated reports that the 70ml centrifuge bowl may leak during cell salvage processing.
The affected products were distributed nationwide to hospitals and medical facilities in Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, and Wisconsin.
The Cell Saver Elite Processing Kit is an accessory component for the Haemonetics Cell Saver 5/5+ System, which is intended for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. Users should stop using the affected kits and contact Haemonetics for further instructions.
The recalled product
- 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 resu
- Manufacturer
- Haemonetics Corporation
- Affected units
- 4,576
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog number: CSE-P-70
Distribution
Part of a larger recall action
This product is one of 2 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.
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