Z-0627-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 10, 2024
- Initiation Date
- November 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 717 units
Product Description
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
Reason for Recall
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Distribution Pattern
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.
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