Haemonetics Recalls Cell Saver 5/5+ Bowl Sets Due to Leakage
Haemonetics is recalling 11,208 units of Cell Saver 5/5+ Bowl Sets because the 70ml centrifuge bowls 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 to patients, 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 11,208 units of the Cell Saver 5/5+ Bowl Set, 70ml (Product IDs: 0291E-00, 0291A-00). The recall was initiated after the company received isolated reports that the 70ml centrifuge bowl may leak during cell salvage processing.
The affected product is intended for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The units were distributed nationwide to 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.
Healthcare facilities should stop using the affected bowl sets and contact Haemonetics Corporation for instructions on how to return or dispose of the product.
The recalled product
- Product
- Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 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 re
- Manufacturer
- Haemonetics Corporation
- Affected units
- 11,208
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 (2)
- Catalog number: 0291A-00
- 0291E-00
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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