CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA
FDA device recall Z-0138-2023 · posted 2022-10-27 · Open, Classified
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury.
- Action taken
- On 8/3/2022, recall notices were mailed to customers who were asked to do the following: 1) Identify affected devices, quarantine, discontinue use and distribution, and return to the recalling firm. 2) If product was further distributed, share the recall notice with these customers/users. 3) Complete and return the customer response form. Customers with questions can contact Customer Service at 801-208-4381, 6AM-6PM, Mon-Fri.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- KNW
- Quantity affected
- 2894
- Distribution
- Worldwide distribution - US National distribution including in the states of FL, IL, OH, PA, CA, WI, VA, AZ, AR, MS, TN, MO, MA, MI, NY, NE, TX, WA, MN, LA, DE, IN, AL, NJ, OR, MD, GA, CT, OK, UT, KS,
- Date initiated
- 2022-08-03
- Date posted
- 2022-10-27
- Location
- South Jordan, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Corvocet Biopsy System (K180450) | Merit Medical Systems, Inc. | 2018-03-12 |