Civco recalls Infinity Needle Guide Brackets due to potential cover leaks during validation testing. Affected units include specific biopsy starter kits with listed lot numbers. Consumers should contact Civco for details.
A cover failed leak testing during validation testing of new needle guides from a replacement tool.
Civco is recalling its Infinity Needle Guide Brackets because a cover failed leak testing during validation of new needle guides. This could lead to improper use during medical procedures if the bracket leaks.
The cover in the needle guide bracket failed leak testing during validation. This means the bracket might leak during medical procedures, potentially causing improper use of the ultrasound transducers.
Physicians using the CIVCO Infinity Needle Guide Brackets with diagnostic ultrasound transducers are affected. Those with the specific biopsy starter kits and listed lot numbers are most at risk.
Check for the product name 'CIVCO lnfiniti Needle Guide Bracket' with specific biopsy starter kits listed in the recall notice. Lot numbers include M206950, M66469: M897110, and others as detailed in the recall.
Reach out to Civco Medical Instruments Co. Inc. for details about the affected units and next steps.
The cover failed leak testing during validation testing of new needle guides, which could lead to improper use during medical procedures.
The CIVCO Infinity Needle Guide Brackets with specific biopsy starter kits and the listed lot numbers, including M206950, M664690, M897110, and others.
Check the lot numbers on your product against the list provided in the recall notice, which includes specific biopsy starter kits and their associated lot numbers.
We’ve drafted a message you can send Civco to request your refund or repair — edit it as you like.
Subject: Recall Z-2888-2018 — Civco Civco Hello, I own a Civco that is covered by recall Z-2888-2018 from Civco. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.