Recall Z-1260-2023
Bard Peripheral Vascular Inc · initiated February 28, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
Codes / lots: REF/UDI-DI/Lot(Expiration Date): 1610MSK/00801741142567/1445630(11/28/2024), 1449980(12/28/2024), 1451134(1/28/2025); 1816MSK/00801741097065/1447510(12/28/2024), 1447511(12/28/2024), 1447512(12/28/2024), 1447513(12/28/2024), 1448118(12/28/2024), 1448119(12/28/2024), 1448120(12/28/2024), 1448121(12/28/2024), 1448743(12/28/2024), 1450413(12/28/2024), 1450414(12/28/2024), 1451075(1/28/2025), 1451076(1/28/2025), 1451621(1/28/2025), 1451622(1/28/2025), 1451625(1/28/2025), 1451626(1/28/2025), 1453516(1/28/2025), 1453517(1/28/2025), 1454295(1/28/2025), 1456850(2/28/2025), 1456856(2/28/2025), 1457030(2/28/2025)
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.
FDA-determined cause: Mixed-up of materials/components
Action taken
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: BDRC3@bd.com 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
Details
- Recall number
- Z-1260-2023
- Initiated
- February 28, 2023
- Posted by FDA
- March 16, 2023
- Product code
- KNW – Instrument, Biopsy
- Quantity
- 38,635
- Distribution
- 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
- Recalling firm
- Bard Peripheral Vascular Inc, Tempe, AZ