CIVCO Recalls SonoSite L25 Bracket Kits Due to Puncture Risk
CIVCO Medical Instruments is recalling SonoSite L25 Bracket Kits because the needle guide bracket may puncture the sterile cover during assembly.
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, and the hazard involves a risk of harm (puncture of sterile cover) where specific injury reports are not detailed in the source text, fitting the criteria for a High severity score.
Plain-English summary
CIVCO Medical Instruments Co., Inc. is recalling 1,375 boxes of SonoSite L25 Bracket Kits. The kits contain one reusable non-sterile bracket with reference numbers P03122-01 through P03122-05, manufactured for SonoSite, Inc. in Bothell, Washington.
The recall was initiated because the needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. This defect could compromise the sterile barrier intended to protect the equipment and patient.
The affected products were distributed in the United States and to numerous foreign countries, including Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom. Affected boxes have lot numbers between A000012-A050663, M000880-M995980, and P022503, as well as all brackets in inventory that no longer have the product labeling. Users should stop using the affected brackets and contact CIVCO Medical Instruments for further instructions.
The recalled product
- Product
- SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05, Mfg for: SonoSite, Inc., Bothell, WA.
- Manufacturer
- CIVCO Medical Instruments Co., Inc.
- Affected units
- 1,375
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)
- Boxes with lot numbers between A000012-A050663
- M000880-M995980
- and P022503
- and all brackets in inventory that no longer have the product labeling.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 15 recalled by CIVCO Medical Instruments Co., Inc. 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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