Bard recalls disposable core biopsy instruments with a penetration depth switch that can detach during use, posing a risk of injury. Affected models include MQ1210 to MQK2016 with specific UDI codes and lot numbers.
Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.
Bard is recalling disposable core biopsy instruments that have a penetration depth switch which can detach during use. This could lead to injury if the detached switch causes the needle to move unexpectedly.
The penetration depth switch, which selects how deep the biopsy needle penetrates soft tissue, can become detached during use. This detachment might cause the needle to move unexpectedly, potentially leading to injury.
Medical professionals who use these instruments for soft tissue biopsies are most at risk. Patients using these instruments for procedures are also affected.
Check for the model numbers listed (MQ1210 to MQK2016) or the UDI codes and lot numbers provided in the recall notice. The instruments are used for soft tissue biopsies and come with specific sizes and weights.
Inspect the penetration depth switch for detachment before use. If detached, stop using the instrument immediately.
Reach out to Bard Peripheral Vascular Inc for specific guidance on affected models and remedies.
The penetration depth switch can detach during use, which might cause the biopsy needle to move unexpectedly and lead to injury.
Affected models include MQ1210 to MQK2016 with specific UDI codes and lot numbers listed in the recall notice.
Check the model number on the instrument or the UDI codes and lot numbers provided in the recall notice.
We’ve drafted a message you can send Bard to request your refund or repair — edit it as you like.
Subject: Recall Z-1289-2021 — Bard Bard Hello, I own a Bard that is covered by recall Z-1289-2021 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.
