CIVCO Needle Guide Bracket Recalled for Puncture Risk
CIVCO Medical Instruments is recalling 738 boxes of Needle Guide Brackets because they 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 involves a risk-of-harm product where the defect may compromise sterility, but no injuries or illnesses have been reported in the source text.
Plain-English summary
CIVCO Medical Instruments Co., Inc. is recalling 738 boxes of CIVCO Needle Guide Brackets, reference numbers M001457100, P06013-10, and P03122-08. These reusable, non-sterile single-angle brackets are intended for use with SonoSite L25 series transducers. The affected units include boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, as well as all brackets in inventory that no longer have product labeling.
The recall was initiated because the needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. This defect poses a risk to the sterile field during medical procedures.
The product was distributed to 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. Users should stop using the affected brackets and contact CIVCO Medical Instruments for instructions on return or replacement.
The recalled product
- Product
- CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.
- Manufacturer
- CIVCO Medical Instruments Co., Inc.
- Affected units
- 738
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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