Bard Peripheral Vascular Inc BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

On 02/11/2021, the firm sent an "UGENT MEDICAL DEVICE RECALL" Notification Letter via FedEx or email to customers/distributors informing them that the Recalling Firm has received reports that 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 and may results in (1) prolongation of the biopsy procedures as the user obtains a replacement device, (2) undershooting the lesion unsuspectedly, compromising the sample quality and potentially leading to a misdiagnosis (3) or if the penetration is overshot, the device may pierce adjacent tissue and/or organs causing injury. Customers are instructed to: 1. Check all inventory locations within their institution for the catalog/lot number combination listed in this recall notice and destroy all affected product remaining in their possession. 2. Share the recall notice with any users of the product, within their facilities, to ensure they are also aware of this recall. 3. If purchased this product from a distributor, contact the distributor for further instructions. 4. Complete and return the attached Customer Response Form to the Recalling Firm's contact noted on the form confirming acknowledgement of the recall notification, whether or not they have any affected product, so that Recalling Firm may acknowledge the receipt of the notification and process any applicable replacement orders. 5. Report any adverse health consequences experienced with the use of this product to the Recalling Firm. Actions to be taken by the Recalling Firm: 1. The firm will process replacement orders for all customers affected by the recall following receipt of the completed Customer Response Form. 2. Depending on the specific product code, there may be delays in the fulfillment of replacement orders. the firm understands that supply interruptions can impact our customers ability to provide the best care for their patients and takes t

Distribution

As reported by FDA

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC, PR