Reported May 14, 2025 · Ongoing

CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR…

Smiths Medical ASD, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Smiths Medical ASD, Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690

Is this the product you have?

21 of 21 products

Products covered by this recall
Model / number	Product as published
`2110`	TRIAL/LOANER, NA ENGLISH 1/EA 21-2111-0300-00 PUMP KIT, CADD-SOLIS HPCA PIB
`2110`	DANISH 1/EA ¿ 21-2111-0300-12 PUMP KIT, CADD-SOLIS HPCA PIB
`2110`	DUTCH 1/EA ¿ 21-2111-0300-06 PUMP KIT, CADD-SOLIS HPCA PIB
`2110`	FRENCH 1/EA ¿ 21-2111-0300-02 PUMP KIT, CADD-SOLIS HPCA PIB
`2110`	GERMAN 1/EA ¿ 21-2111-0300-03 PUMP KIT, CADD-SOLIS HPCA PIB
`2110`	ITALIAN 1/EA ¿ 21-2111-0300-07 PUMP KIT, CADD-SOLIS HPCA PIB
`2110`	JAPANESE 21-2111-0300-09JP PUMP KIT, CADD-SOLIS HPCA PIB
`2110`	NA ENGLISH 1/EA ¿ 21-2111-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB
`2110`	NFHU, FRENCH 1/EA ¿ 21-2111-0300-232 PUMP KIT, CADD-SOLIS HPCA PIB
`2110`	NFHU, NA ENGLISH 1/EA ¿ 21-2111-0300-231 PUMP KIT, CADD-SOLIS HPCA PIB
`2110`	NFHU, SWEDISH 1/EA 21-2111-0300-244 PUMP KIT, CADD-SOLIS HPCA PIB
`2110`	OUS ENGLISH 1/EA ¿ 21-2111-0300-50 Not PUMP KIT, CADD-SOLIS HPCA PIB
`2110`	PORTUGUESE 1/EA ¿ 21-2111-0300-17 PUMP KIT, CADD-SOLIS HPCA PIB
`2110`	SPANISH 1/EA ¿ 21-2111-0300-08 PUMP KIT, CADD-SOLIS HPCA PIB
`2110`	SWEDISH 1/EA ¿ 21-2111-0300-14 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD
`2110`	NA ENGLISH 1/EA ¿ 21-2112-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW
`2110`	DUTCH 1/EA 21-2112-0300-06 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW
`2110`	FRENCH 1/EA ¿ 21-2112-0300-02 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW
`2110`	GERMAN 1/EA 21-2112-0300-03 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW
`2110`	OUS ENGLISH 1/EA 21-2112-0300-50 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW

Lot codes and dates: All CADD-Solis and CADD-Solis
VIP Ambulatory Infusion Pumps UDI-DI
142 of 142 codes
10610586034787
10610586038778
10610586038785
10610586038808
10610586038822
10610586039232
10610586041037
10610586041051
10610586042591
10610586042669
10610586042829
10610586042836
15019517084368
15019517096378
15019517096385
15019517096392
15019517099690
15019517101003
15019517101010
15019517101034
15019517101041
15019517126587
15019517126594
15019517126600
15019517126617
15019517128697
15019517135343
15019517149999
15019517150001
15019517150292
15019517154290
15019517154887
15019517154924
15019517154979
15019517154986
15019517154993
15019517155006
15019517155013
15019517155044
15019517246735
15019517247008
15019517247169
15019517247176
15019517247183
15019517247206
00610586038900
00610586039310
04546027095620
04546027095637
04546027095644
04546027095668
04546027095675
04546027095682
04546027095699
04546027095705
04546027095712
04546027095729
04546027095736
04546027095743
04546027095897
15019517150124¿
15019517150131
15019517150179
15019517150193
15019517150216
15019517150278
15019517150308
15019517150315
15019517150322
15019517150391
30610586035344
30610586035368
30610586035511
30610586039205
30610586039397
30610586040430
30610586040539
35019517128677
35019517128684
35019517128691
35019517128721
35019517128738
35019517128745
35019517128769
35019517128783
35019517128837
35019517135316
35019517135323
35019517135330
35019517135354
35019517135361
35019517154850
35019517154867
35019517154874
35019517154904
35019517154911
35019517154942
35019517154959
35019517154966
35019517155031
35019517155055
35019517155062
35019517155079
35019517155086
35019517155130
Amount recalled: 185,975 US; 127,701 OUS Total

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

Nationwide

Why it was recalled

Stop using this product now

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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