Haemonetics Recalls Cell Saver Elite Fastpacks Due to Potential Bowl Cracks
Haemonetics is recalling Cell Saver Elite Fastpacks because cracks in the bowl core may cause fluid trapping and incomplete blood washing.
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 defect that could lead to incomplete washing of blood products, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Haemonetics Corporation is recalling 8,114 units of the Japan CS Elite Fastpack, 225ml. These medical device components are used to recover, process, and reinfuse blood during or after surgery or trauma. 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.
The recall was initiated because the bowl sets have the potential to develop leaks at the inner core. This defect can result in fluid being trapped inside the bowl core, which may cause a long empty device error message and the possibility of incomplete washing of the blood product.
The affected products were distributed worldwide, including nationwide in the United States and in various countries in Asia, Europe, and Oceania. Users should stop using the affected products and contact Haemonetics Corporation for further instructions.
The recalled product
- Product
- JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed re
- Manufacturer
- Haemonetics Corporation
- Affected units
- 8,114
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 (6)
- 1118017-1118031181226H11118019
- 1118017-1118031181226H11118063
- 1118017-1118032181226H11118063
- 1118017-1118081190124H10119084
- 1118017-1118082190124H10119002
- 1118017-1118082190124H20119002
Distribution
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.
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