Sterilmed Recalls Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters
Sterilmed is recalling 22 reprocessed diagnostic ultrasound catheters because they were incorrectly processed. The affected units were distributed in Washington and California.
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 is classified as FDA Class II, which typically involves a risk of temporary or medically reversible health consequences. As no specific injuries or illnesses are reported in the source text, the score is set to High (3) per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sterilmed, a division of Johnson & Johnson Medical NV/SA, is recalling 22 units of Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters. Sterilmed serves as the reprocessor for these devices, while Biosense Webster acts as the distributor. The recall involves specific catalog and model numbers, including Catalog No. M-5723-115 and Model Number BIO10438577.
The recall was initiated because Sterilmed determined that the units in the affected lots were incorrectly processed. The source text indicates that the issue affects the catheters when connected, though the specific nature of the malfunction is not fully detailed in the provided excerpt. The affected lot numbers are 1717945, 1721574, 1721575, and 1723123.
The affected products were distributed in the United States, specifically in the states of Washington and California. Healthcare facilities and consumers who possess these specific devices should stop using them and contact Sterilmed or Biosense Webster for instructions on return or replacement.
The recalled product
- Product
- Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
- Manufacturer
- STERILMED, INC.
- Hazard
- Affected units
- 22
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 (4)
- Lot Numbers: 1717945
- 1721574
- 1721575 and 1723123 Catalog Nos: M-5723-115
- Model Number BIO10438577
Distribution
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