Recall Z-2295-2025
Merit Medical Systems, Inc. · initiated June 5, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
Codes / lots: REF/UDI-DI/Lot(Expiration): K09-02239C/00884450204313/H3111528(10/31/2027), H3157165(10/31/2027); K09-02249UP/00884450330043/H3116232(8/26/2026), H3156392(8/31/2026), H3173422(8/31/2026), H3178693(8/31/2026), H3190348(3/16/2028), H3195871(3/31/2028), H3205105(4/7/2028); K09-09110B/00884450279076/H3163891(3/21/2028); K09-10294A/ 00884450210000/H3169190(4/30/2027); K09-11227A/00884450210697/H3156393(2/10/2028), H3157208(2/17/2028); K09-11456B/00884450279717/H3112605(8/31/2026), H3156272(8/31/2026); K09-12123B/00884450741146/H3167049(3/2/2028); K09-13342AP/00884450548714/H3119448(10/31/2027), H3127766(10/31/2027), H3152497(1/25/2028), H3152498(1/25/2028), H3157249(1/31/2028), H3170462(3/7/2028), H3196372(3/21/2028), H3205117(4/5/2028); K09-13391BP/00884450752111/H3128003(10/31/2027), H3152494(7/31/2027), H3170418(10/31/2027), H3173459(10/31/2027), H3184951(3/9/2028), H3190567(8/31/2026); K09-13548/00884450582329/H3156627(2/19/2028) K09-14000A/00884450785102/H3125122(11/30/2027), H3136598(11/30/2027) K09T-12020D/00884450860007/T3147714(4/24/2027), T3163752(8/1/2027) K09T-12275B/00884450640500/T3186397(2/22/2027)
Reason for recall
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
FDA-determined cause: Process control
Action taken
On 5/5/2025, recall notices were emailed to customers who were asked to do the following: 1) Identify affected devices and quarantine, discontinue use and distribution. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the customer response form. 4. Return all affected devices to the firm. 5. Complete, and return the customer response form via email to response@merit.com If you have questions, contact the firm's customer service at RESPONSE@merit.com or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri
Details
- Recall number
- Z-2295-2025
- Initiated
- June 5, 2025
- Posted by FDA
- August 12, 2025
- Product code
- OEZ – Cardiovascular Procedure Kit
- Quantity
- 6327
- Distribution
- US Nationwide distribution in the states of OH, CA, SD, VA, AZ, MT, TX, MI, FL, TN, PA, NJ, MN, ND, IA, LA, UT, KY, IL, OK, ME, IN, NY, NM, SC, AL, ID, CT, WI, GA, MA, NC, AR, WA.
- Recalling firm
- Merit Medical Systems, Inc., South Jordan, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2293-2025 Class II | High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/CHigh pressure tubing may relax over time causing it to partially separate from the connector resulting in a… | 06/05/2025Open, Classified |
| Z-2294-2025 Class II | Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029High pressure tubing may relax over time causing it to partially separate from the connector resulting in a… | 06/05/2025Open, Classified |
| Z-2296-2025 Class II | Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B…High pressure tubing may relax over time causing it to partially separate from the connector resulting in a… | 06/05/2025Open, Classified |