Recall Z-0138-2023
Merit Medical Systems, Inc. · initiated August 3, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA1410S/CNB, CORCA1415S/B, CORCA1610/CNB, CORCA1615S/CNB, CORCA1810SB/CNB, CORCA1815SB/CNB, CORCA1820SB/CNB, CORCA2015SB/CNB, CORCA2020SB/CNB
Codes / lots: Catalog Code-Lot (OUS Distribution Only): CORA1410/B- I2206909, I2318475, I2291980, I2286704; CORA1410S/B- I2206888; CORA1415/B- I2213361; CORA1615S/B- I2114518, H1517631, H1715532, H1756745, H1767115, H1771762, H1776067, H1784861, H1800979, H1808121, H1825693, I1781878, I1818817, I1837234, I1843704, I1855418, I1866359, I1952354, I1958525, I1971876, I1990075, I1998862, I2043630, I2070249, I2075810; CORA2010S/B- I2010414; CORCA1410S/B- I2259093; CORCA1410S/CNB- I2305358; CORCA1415S/B- I2210950; CORCA1610/CNB- I2291983; CORCA1615S/CNB- I2330683; CORCA1810SB/CNB- I2305359; CORCA1815SB/CNB- I2170254, I2205164; CORCA1820SB/CNB- I2325912; CORCA2015SB/CNB- I2318903, I2325926; CORCA2020SB/CNB- I2320880
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.
FDA-determined cause: Process change control
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.
Details
- Recall number
- Z-0138-2023
- Initiated
- August 3, 2022
- Posted by FDA
- October 27, 2022
- Product code
- KNW – Instrument, Biopsy
- Quantity
- 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, NC, CO, KY, WV, AK, NV, RI, SC, ND, NH, MT and the countries of Finland, Denmark, United Arab Emirates, Spain, Sweden, Norway, Jordan, Australia, Germany, Austria, Italy, United Kingdom, France…
- Recalling firm
- Merit Medical Systems, Inc., South Jordan, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0137-2023 Class II | CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A…Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly… | 08/03/2022Open, Classified |