Recall archive / FDA device enforcement

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous,... — FDA record Z-2420-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 27, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
Reason: The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.
Classification: Class I
Recalling firm: Smiths Medical ASD Inc.
Quantity: Not supplied
Agency-reported status: Ongoing
Source record identifier: Z-2420-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	REF List Number 21-2111-0100-00, UDI/DI 10610586039195, Serial Numbers: 10610586039195; REF List Number 21-2111-0100-51, UDI/DI 30610586039205, Serial Numbers: 1008871, 1011314, 1011695, 1012140, 1012157, 1012387, 1012393, 1012430, 1012607, 1012611, 1012749, 1012751, 1012752, 1012758, 1012765, 1012767, 1012769, 1012773, 1012815, 1012988, 1013182, 1013185, 1013186, 1013187, 1013219, 1013221, 1013223, 1013230, 1013235, 1013237, 1013239, 1013251, 1013256, 1013264, 1013265, 1013278, 1013282, 1013291, 1013295, 1013301, 1013562, 1013817, 1013824, 1013853, 1013866, 1013953, 1013979, 1014000, 1014064, 1014103, 1014117, 1014279, 1014282, 1014288, 1014302, 1014308, 1014447, 1014463, 1016862, 1016876, 1016881, 1014804, 1014806, 1014811, 1014831, 1014844, 1014861, 1014880, 1014895, 1015034, 1015375, 1015382, 1016292, 1016522, 1016709, 1038360, 1016879, 1016927, 1016961, 1023905, 1016989, 1016990, 1017003, 1017005, 1017006, 1017049, 1017051, 1017075, 1017096, 1017143, 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1024202, 1024218, 1024219, 1024223, 1024224, 1024225, 1024230, 1024232, 1024233, 1024234, 1016471, 1024690, 1024691, 1025322, 1025344, 1025346, 1029435, 1015489, 1022032, 1013091, 1024665, 1024666, 1024704, 1024705, 1024706, 1024707, 1024708, 1024709, 1024710, 1024712, 1024714, 1024715, 1024716, 1024718, 1024719, 1024720, 1024721, 1024722, 1024723, 1024724, 1024725, 1016343, 1025324, 1021442, 1021443, 1021444, 1021448, 1021511, 1114780, 1022175, 1017759, 1015065; REF List Number 21-2111-0200-06, UDI/DI 10610586039430, Serial Numbers: 1021051, 1021052, 1021053, 1021054, 1021055, 1021056, 1021057, 1021058, 1021512, 1021513; REF List Number 21-2111-0300-00, UDI/DI 10610586038792, Serial Numbers: 1047706, 1078090, 1078327, 1078337; REF List Number 21-2111-0300-01, UDI/DI 10610586038778, Serial Numbers: 1003302, 1003614, 1005310, 1005321, 1011210, 1012744, 1014286, 1063228, 1014808, 1014877, 1016779, 1017035, 1017038, 1017156, 1017169, 1017178, 1017182, 1017183, 1017184, 1017185, 1017192, 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1098858, 1098859, 1069241, 1069242, 10...

Label field

Details supplied by the agency

Lot, code or applicability

REF List Number 21-2111-0100-00, UDI/DI 10610586039195, Serial Numbers: 10610586039195; REF List Number 21-2111-0100-51, UDI/DI 30610586039205, Serial Numbers: 1008871, 1011314, 1011695, 1012140, 1012157, 1012387, 1012393, 1012430, 1012607, 1012611, 1012749, 1012751, 1012752, 1012758, 1012765, 1012767, 1012769, 1012773, 1012815, 1012988, 1013182, 1013185, 1013186, 1013187, 1013219, 1013221, 1013223, 1013230, 1013235, 1013237, 1013239, 1013251, 1013256, 1013264, 1013265, 1013278, 1013282, 1013291, 1013295, 1013301, 1013562, 1013817, 1013824, 1013853, 1013866, 1013953, 1013979, 1014000, 1014064, 1014103, 1014117, 1014279, 1014282, 1014288, 1014302, 1014308, 1014447, 1014463, 1016862, 1016876, 1016881, 1014804, 1014806, 1014811, 1014831, 1014844, 1014861, 1014880, 1014895, 1015034, 1015375, 1015382, 1016292, 1016522, 1016709, 1038360, 1016879, 1016927, 1016961, 1023905, 1016989, 1016990, 1017003, 1017005, 1017006, 1017049, 1017051, 1017075, 1017096, 1017143, 1017146, 1017159, 1017161, 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1069242, 10...

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Match all identifying details in the current notice. A brand name alone is not enough.

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Worldwide

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Dates in the source

Report date: Aug 14, 2024
Recall initiation date: Feb 27, 2024
Center classification date: Aug 2, 2024

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