| | Class 2 Device Recall Custom Manifold Kit |  |
| Date Initiated by Firm | June 05, 2025 |
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| Date Posted | August 12, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2295-2025 |
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| Recall Event ID |
97151 |
| Product Classification |
Cardiovascular procedure kit - Product Code OEZ
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| 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 |
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| Code Information |
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)
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| FEI Number |
1721504
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Recalling Firm/
Manufacturer |
Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
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| For Additional Information Contact |
801-253-1600 |
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Manufacturer 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.
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FDA Determined
Cause 2 | Process control |
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| Action | 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 |
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| Quantity in Commerce | 6327 |
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| 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.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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