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Open, Classified

Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK

FDA Recall Z-1260-2023 · Posted 2023-03-16

Recall StatusOpen, Classified
Product CodeKNW
Date Initiated2023-02-28
Product Quantity38,635

Reason for Recall

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.

Firm Action

On 2/28/23, "URGENT MEDICAL DEVICE RECALL" notices were mailed and emailed to customers and distributors who were told to take the following actions: 1) Discontinue use of and Dispose of all affected product remaining in your possession in accordance with your local facility's process. 2) Share this notification with all users within your facility network of the product to ensure they are also aware of this field action. 3) If you purchased this product from a distributor, contact your distributor for further instructions and credit resolution. 4) Complete and return the attached Customer Response Form and email to: [email protected] The recalling firm will issue replacements, as available, or credit. In addition, distributors were asked to do the following: Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this field action notification. Customers/distributors who have questions can contact the North American Regional Complaint Center at 1-844-8BD- LIFE (1-844-823-5433), Say Recall when prompted, M-F 8am - 5pm CT

Root Cause

Mixed-up of materials/components

Distribution Pattern

Worldwide Distribution: US (Nationwide) includes states of: FL, MD, OH, CO, PA, TX, NC, CA, ME, MO, NV, MI, IL, NY, VA, AZ, NH, LA, WI, KY, MA, WA, CT, SD, OK, DC, IA, AR, GA, NE, NM, IN, NJ, MN, PR, AL, AK, SC, KS, OR, ID, VT, MT, WV, ND, TN, MS, HI, WY, RI and OUS countries of: Canada, Korea, Thailand and Taiwan. OUS: AR, AU, BE, CA, CN, CO, HK, IN, JP, KR, TH, TW

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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