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U.S. Department of Health and Human Services

Class 2 Device Recall Merit Maestro Microcatheter

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  Class 2 Device Recall Merit Maestro Microcatheter see related information
Date Initiated by Firm November 06, 2023
Date Posted January 02, 2024
Recall Status1 Open3, Classified
Recall Number Z-0627-2024
Recall Event ID 93461
510(K)Number K172081  
Product Classification Catheter, continuous flush - Product Code KRA
Product Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B,
28MC21110ST/B,
28MC2113045/B,
28MC21130SN/CNB,
28MC21130ST/B,
28MC2115045/B,
28MC2115045/C,
28MC21150SN/B,
28MC21150ST/B,
28MC2411045/D,
28MC24110SN/D,
28MC24110ST/D,
28MC2413045/D,
28MC24130SN/F,
28MC24130ST/D,
28MC24130ST-W/A,
28MC2415045/D,
28MC24150ST/D,
28MC24150ST/F,
28MC28110ST/D,
28MC2813045/D,
28MC28130SN/D,
28MC28130SN/F,
28MC28130ST/D,
28MC28150SN/D,
28MC28150SN/F,
29MC2911045/D,
29MC29130SN/F,
29MC29130ST/D,
29MC29150ST/CNB,
29MC29150ST/D, CE 2797, STERILEEO, Rx ONLY
Code Information Ref:28MC2111045/B - Lot # H2775120 - UDI: 00884450335215; Ref: 28MC21110ST/B- Lot # H2750697 and H2775121 - UDI: 00884450335239; Ref:28MC2113045/B- Lot # H2750699, H2763805, H2775122 - UDI: 00884450335246; Ref:28MC21130SN/CNB- Lot # H2747446-UDI:00884450335253; Ref:28MC21130ST/B- Lot # H2750708 - UDI: 00884450335260 Ref:28MC2115045/B- Lot # H2750484 - UDI: 00884450335277 Ref:28MC2115045/C- Lot # H2750714 - UDI: 00884450442456 Ref:28MC21150SN/B- Lot # H2750715 and H2769214 00884450335284 Ref:28MC21150ST/B- Lot # H2750719 - UDI: 00884450335291 Ref:28MC2411045/D- Lot # H2750721 and H2769962 - UDI: 00884450357903 Ref:28MC24110SN/D- Lot # H2750518 - UDI: 00884450357910 Ref:28MC24110ST/D- Lot # H2750733 - UDI: 00884450357927 Ref:28MC2413045/D- Lot # H2766010 - UDI: 00884450357934 Ref:28MC24130SN/F- Lot # H2750372 00884450358207 Ref:28MC24130ST/D- Lot # H2750747 and H2779460 UDI: 00884450357958 Ref:28MC24130ST-W/A- Lot # H2777603 00884450324592 Ref:28MC2415045/D- Lot # H2750756, H2766011, H2769993, UDI: 00884450357965 Ref:28MC24150ST/D- Lot # H2750768-UDI: 00884450357989 Ref:28MC24150ST/F- Lot # H2749681-UDI: 00884450358245 Ref:28MC28110ST/D- Lot # H2770003- UDI: 00884450358016 Ref:28MC2813045/D- Lot # H2770016- UDI: 00884450358023 Ref:28MC28130SN/D- Lot # H2770029 and H2785162 - UDI: 00884450358030 Ref:28MC28130SN/F- Lot # H2750378 UDI: 00884450358290 Ref:28MC28130ST/D- Lot # H2752481 and H2766013 - UDI: 00884450358047 Ref:28MC28150SN/D- Lot # H2756905 and H2765969 - UDI: Ref:28MC28150SN/F- Lot # H2750387 UDI: 00884450358320 Ref:29MC2911045/D- Lot # H2758290 00884450358085 Ref:29MC29130SN/F- Lot # H2750390 00884450358382 Ref:29MC29130ST/D- Lot # H2750599 00884450358139 Ref:29MC29150ST/CNB- Lot # H2756603 00884450038383 Ref:29MC29150ST/D- Lot # H2749336,H2765976 and H2770087 - UDI: 00884450358160
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact Ms. Hannah Gay
801-253-1600
Manufacturer Reason
for Recall		 The sterility of microcatheter and infusion system devices cannot be guaranteed.
FDA Determined
Cause 2		 Package design/selection
Action On November 6, 2023, Merit Medical issued a Urgent Medical Device Recall Notice to affected consignees via Email or UPS. Merit Medical asked consignees to take the following actions: 1. Immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. 2. 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 CRF. Additional distribution details may be required by health authorities. 4. Please fill out, scan and email the completed Customer Response Form to Customer Service at response@merit.com within seven (7) days. All affected product shipped to you must be accounted for on the CRF. 5. Please immediately return all affected lots in your possession to Merit, per the instructions in the attached CRF.
Quantity in Commerce 717 units
Distribution Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, MA, MD, MN, MO, NH, NJ, NSW, NV, NY, UT, WI and the countries of Argentina, Australia, Belgium, China, France, Germany, Guam, Hong Kong, Italy, Mexico, Netherlands, Switzerland.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = KRA and Original Applicant = Merit Medical Systems, Inc.
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