Boston Scientific RX Cholangiogram Kit Recall Due to Sterile Barrier Breach
Boston Scientific is recalling RX Cholangiogram Kits because the sterile barrier has been breached, compromising the sterility of the devices. The affected kits were distributed worldwide.
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: This is an FDA Class II recall involving a sterile barrier breach on a medical device used in invasive procedures. No hospitalizations, injuries, or deaths have been reported in the source material. However, the compromised sterility presents a risk of infection, fitting the rubric criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling RX Cholangiogram Kits due to a sterile barrier breach that compromises the sterility of the devices. The recalled kits have material numbers M00575240, M00575280, M00575320, M00575360, M00575380, M00575400, M00575440, and M00575480.
Affected units were distributed worldwide, including throughout the United States and to Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, and the United Arab Emirates. Specific lot numbers associated with each material number have been identified.
Consumers and healthcare providers who have received these kits should not use them. Contact Boston Scientific Corporation for instructions on returning the affected devices or obtaining replacements.
The recalled product
- Product
- RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 31 recalled by Boston Scientific 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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