Haemonetics Recalls Cell Saver Bowl Sets Due to Leak Risk
Haemonetics is recalling Cell Saver bowl sets because cracks in the inner core may cause leaks and incomplete blood 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 involves a medical device defect that could lead to incomplete washing of blood products, posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Haemonetics Corporation is recalling specific lots of the Japan Basic Hi Speed CS5 Set (LN 263J) and related Cell Saver 5/5+ and Elite/Elite +125ml and 225ml bowl sets. The recall affects 28,462 units distributed worldwide, including nationwide distribution in the United States and in countries such as New Zealand, Australia, India, Pakistan, the Philippines, and several European nations.
The recall was initiated due to a potential for leaks at the inner core of the bowl sets. This defect can result in fluid being trapped inside the bowl core, which may trigger a long empty device error message and lead to the possibility of incomplete washing of the recovered blood product.
Healthcare facilities and users should stop using the affected bowl sets immediately. The specific lot number 0718027 is identified as having bowl cracks, and the recall also covers products manufactured between October 2014 and October 2019 that are missing instructions to check for cracks in the Instructions for Use (IFU).
The recalled product
- Product
- JAPAN BASIC HI SPEED CS5 SET,LN 263J - 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. The recovered blood is processed by a centrifugation and…
- Manufacturer
- Haemonetics Corporation
- Hazard
- Affected units
- 28,462
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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