Bard recalls EnCor Breast Biopsy Probes due to leaks and suction problems that may cause failed tissue sampling. Affected units include specific model and lot numbers.
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
Bard is recalling EnCor Breast Biopsy Probes because they have been reported to leak and cause suction issues, which might lead to failed tissue sampling during breast biopsies. This affects medical devices used for diagnosing breast abnormalities.
The probes can leak or have suction problems, which might prevent proper tissue sampling during breast biopsies. This could lead to failed procedures and the need for repeat tests.
Healthcare providers who use these probes for breast biopsies are most at risk. Patients undergoing the procedure may be affected if the probes fail to obtain samples.
Check for the product name 'EnCor Breast Biopsy Probes' in sterile pouches, 5 per carton. Lot number VTCW046:12GV Upright (Vertical) - REF ECP0112GV.
Look for the lot number VTCW0467 and reference number ECP0112GV on the packaging.
Bard recalls these probes due to reported leaks and suction issues that may cause failed tissue sampling during breast biopsies.
The recall record does not specify a remedy, so check the product details and contact Bard for further instructions.
The recall indicates potential issues with leaks and suction, which could lead to failed procedures, but no specific injury risks are mentioned.
We’ve drafted a message you can send Bard to request your refund or repair — edit it as you like.
Subject: Recall Z-2212-2019 — Bard Bard Hello, I own a Bard that is covered by recall Z-2212-2019 from Bard. 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.
