SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01
FDA device recall Z-1475-2017 · posted 2017-02-28 · Terminated
Recall details
- Recalling firm
- Medtronic
- Reason for recall
- Handle may break during use.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FCG
- Quantity affected
- 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 a
- Date initiated
- 2017-02-08
- Date posted
- 2017-02-28
- Date terminated
- 2019-07-18
- Location
- North Haven, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BNX FINE NEEDLE ASPIRATION SYSTEM (K103668) | Boston Endoscopic Engineering | 2010-12-30 |