Reprocessed Webster CS Catheter 10 Electrodes for recall: Particulate Matter
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH…
Why was Reprocessed Webster CS Catheter 10 Electrodes for recalled?
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item Number/UDI-DI BD710DF282CRH 10197344044023; BD710DF282RRH 10197344044030; BD710FJ282CRH 10197344044047; BD710FJ282RRH 10197344044054; LOTS EP241216 EP241218 EP241226 EP241231 EP250110 EP250121 EP250210
- Product
- Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH…
- Recalling firm
- Medline Industries, LP
- Quantity
- 7913 eaches
- Distribution
- Domestic US distribution nationwide. International distribution pending. No international distribution.
- Recall date
- October 8, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)