Bard recalls specific disposable core biopsy instrument kits due to potential needle tip breakage when used with incompatible instruments, which may require additional devices or cause procedural delays.
The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if used despite incompatibility.
Bard is recalling two specific disposable core biopsy instrument kits that could cause needle tip breakage if used incorrectly. This poses a risk of needing extra tools or delaying medical procedures during procedures.
The biopsy instrument's outer diameter is larger than the inner diameter of the coaxial needle. This mismatch can cause the needle tip to break during use, requiring additional devices or causing procedural delays.
Medical professionals using the recalled biopsy kits for procedures are most at risk. Patients receiving these kits during procedures may be affected if the instruments are used incorrectly.
Check for the model numbers 16G x 10CM (REF: 1610MSK) or 18G x 16CM (REF: 1816MSK). The kits were sold with specific expiration dates and lot numbers listed in the recall notice.
Review the product's model number and reference code to confirm if it matches the recalled kits (1610MSK or 1816MSK).
The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to needle tip breakage, procedural delays, or requiring additional devices.
The recall does not specify a remedy, so check the product details to confirm if it's affected and contact Bard for further instructions.
Using the kit with incompatible instruments could cause needle tip breakage, which may require additional devices or delay procedures.
We’ve drafted a message you can send Bard to request your refund or repair — edit it as you like.
Subject: Recall Z-1260-2023 — Bard Bard Hello, I own a Bard that is covered by recall Z-1260-2023 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.