Merit Medical Systems, Inc. recalls Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-D

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Recalled Product

Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI codes: 00884450529645 00884450529669 REF: MSWSTDA35260EX UDI-DI code: 00884450529683 REF: MSWSTDA3580 UDI-DI codes: 00884450529645 00884450529690 00884450529744 REF: MSWSTDS35150 UDI-DI codes: 00884450529690 00884450529744 REF: MSWSTFA35260EX UDI-DI code: 00884450529447 REF: MSWSTFA3580 UDI-DI code: 00884450529515 REF: MSWSTFS35150 UDI-DI code: 00884450529553 The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.

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Hazard / Issue

Due to unsealed portions of pouches.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: REF: MSWSTDA35150 UDI-DI code: 00884450529645 Lot Numbers: K3410951 K3420005 K3420006 K3420007 K3420106 UDI-DI code: 00884450529669 Lot Number: K3420005 UDI-DI code: 00884450529690 Lot Number: K3420006 REF: MSWSTDA35180 UDI-DI code: 00884450529645 Lot Number: K3405121 UDI-DI code: 00884450529669 Lot Numbers: K3405121 K3405126 K3405127 K3405128 K3405129 K3405130 K3410953 K3420010 REF: MSWSTDA35260EX UDI-DI code: 00884450529683 Lot Numbers: K3405122 K3410937 K3410958 REF: MSWSTDA3580 UDI-DI code: 00884450529645 Lot Number: K3405257 UDI-DI code: 00884450529690 Lot Number: K3405257 UDI-DI code: 00884450529744 Lot Number: K3405257 REF: MSWSTDS35150 UDI-DI code: 00884450529690 Lot Number: K3420082 UDI-DI code: 00884450529744 Lot Numbers: K3420082 K3420101 REF: MSWSTFA35260EX UDI-DI code: 00884450529447 Lot Number: K3405261 REF: MSWSTFA3580 UDI-DI code: 00884450529515 Lot Number: K3420079 REF: MSWSTFS35150 UDI-DI code: 00884450529553 Lot Number: K3399729

✅ What Should You Do?

1Contact your healthcare provider immediately to discuss this recall.
2Stop using the device if it is safe to do so, and contact your provider.
3Follow the manufacturer's remedy instructions provided in the recall notice.
4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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Merit Medical Systems, Inc. recalls Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-D

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