Recall Z-1474-2017
Medtronic · initiated February 8, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01
Codes / lots: Lot number: B000000174
Reason for recall
Handle may break during use.
FDA-determined cause: Nonconforming Material/Component
Action taken
A recall was initiated on February 8, 2017. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 1856 Corporate Dr. Suite 140 Norcross, GA 30093, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices: Will be reworked.
Details
- Recall number
- Z-1474-2017
- Initiated
- February 8, 2017
- Posted by FDA
- February 28, 2017
- Terminated
- July 18, 2019
- Product code
- FCG – Biopsy Needle
- Quantity
- 1,096 Units (total for all products)
- Distribution
- US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE
- Recalling firm
- Medtronic, North Haven, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1472-2017 Class II | BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01Handle may break during use. | 02/08/2017Terminated |
| Z-1473-2017 Class II | SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01Handle may break during use. | 02/08/2017Terminated |
| Z-1475-2017 Class II | SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01Handle may break during use. | 02/08/2017Terminated |
| Z-1476-2017 Class II | BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01Handle may break during use. | 02/08/2017Terminated |