Blood transfusion filters recalled over unconfirmed sterility assurance before release
GVS TM is recalling 2,720 SQ40S Blood Transfusion Filters from one lot because they were released for distribution before the required quality control release process was completed.
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: Scored 3 under the risk-of-harm criterion: sterility cannot be confirmed for a device used in the blood transfusion path, and no injuries are reported.
Plain-English summary
The SQ40S Blood Transfusion Filter is being recalled by GVS TM, Inc.
The reason given in the enforcement record is that, due to products being released for distribution prior to completion of the required quality control release process, sterility assurance cannot be confirmed.
The record lists 2,720 filters under product number SQ40S, UDI-DI 10887691000666, lot number 7536142. Distribution covered a wide range of US states listed in the enforcement record. The FDA has classified the action as Class II.
A filter used in the blood transfusion path whose sterility cannot be confirmed carries an infection risk. The enforcement record reports no injuries. Facilities should quarantine the affected lot and follow the firm's instructions.
The recalled product
- Product
- Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
- Manufacturer
- RAYSEARCH LABORATORIES AB
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 recalled by RAYSEARCH LABORATORIES AB 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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