| | Class 1 Device Recall CADD |  |
| Date Initiated by Firm | April 10, 2025 |
|---|
| Date Posted | May 07, 2025 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1667-2025 |
|---|
| Recall Event ID |
96620 |
| 510(K)Number | K072144 K130394 K170982 |
|---|
| Product Classification |
Pump, infusion, pca - Product Code MEA
|
| Product | CADD-Solis HPCA Ambulatory Infusion Pump;
Model/Number:
21-2111-0402-09-KYO
21-2111-0402-09-KYO
CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP
21-2111-0300-09_LOAN
CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA
21-2111-0300-09_CMSA
CADD Solis PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR FUKUOKA
21-2111-0300-09_FUK
CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR KYOTO
21-2111-0300-09_KYO
CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OKAYAMA
21-2111-0300-09_OKA
CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OOMIYA
21-2111-0300-09_OMI
CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OSAKA
21-2111-0300-09_OSA
CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR SAPPORO
21-2111-0300-09_SAP
CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR TOKYO
21-2111-0300-09_TOK
CADD_SOLIS_MODEL 2110_ENGLISH_1/EA
21-2111-0200-50JP
CADD-Solis VIP
CADD-SOLIS V4.2 LOAN FUK
21-2111-0402-09-FUK
CADD-SOLIS V4.2 LOAN NAG
21-2111-0402-09-NAG
CADD-SOLIS V4.2 LOAN OKA
21-2111-0402-09-OKA
CADD-SOLIS V4.2 LOAN OSA
21-2111-0402-09-OSA
CADD-SOLIS V4.2 LOAN SAI
21-2111-0402-09-SAI
CADD-SOLIS V4.2 LOAN SAP
21-2111-0402-09-SAP
CADD-SOLIS V4.2 LOAN TOKE
21-2111-0402-09-TOKE
CADD-SOLIS V4.2 LOAN TOKW
21-2111-0402-09-TOKW
CADD-SOLIS V4.2 LOAN YELLOW KYO
21-2112-0402-09-KYO
CADD-SOLIS V4.2 LOAN YELLOW NAG
21-2112-0402-09-NAG
CADD-SOLIS V4.2 LOAN YELLOW YOK
21-2112-0402-09-YOK
CADD-SOLIS V4.2 LOAN YOK
21-2111-0402-09-YOK
Number:21-2111-0403-02Part Type:List Number/Finished GoodLifecycle Phase:03-ReleasedDescription:PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, FRENCH, 1/EA
21-2111-0403-02
PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA
21-2111-0403-51
PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, ENGLISH, 1/EA
21-2111-0403-78
PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, YELLOW, ENGLISH, 1/EA
21-2112-0403-78
PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, ENGLISH, 1/EA
21-2112-0403-51
PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, FRENCH, 1/EA
21-2112-0403-02
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA
21-2111-0300-00
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, DANISH 1/EA
21-2111-0300-12
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, DUTCH 1/EA
21-2111-0300-06
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, FRENCH 1/EA
21-2111-0300-02
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, GERMAN 1/EA
21-2111-0300-03
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, ITALIAN 1/EA
21-2111-0300-07
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, JAPANESE
21-2111-0300-09JP
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA
21-2111-0300-01
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, FRENCH 1/EA
21-2111-0300-232
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, NA ENGLISH 1/EA
21-2111-0300-231
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, SWEDISH 1/EA
21-2111-0300-244
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA
21-2111-0300-50
Not
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, PORTUGUESE 1/EA
21-2111-0300-17
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, SPANISH 1/EA
21-2111-0300-08
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, SWEDISH 1/EA
21-2111-0300-14
PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA
21-2112-0300-01
PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, DUTCH 1/EA
21-2112-0300-06
PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, FRENCH 1/EA
21-2112-0300-02
PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, GERMAN 1/EA
21-2112-0300-03
PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA
21-2112-0300-50
PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110,TRIAL/LOANER, NA ENGLISH 1/EA
21-2112-0300-00
PUMP KIT, CADD-SOLIS HPCA, MDL 2100, DANISH 1/EA
21-2101-0200-12
PUMP KIT, CADD-SOLIS HPCA, MDL 2100, FRENCH 1/EA
21-2101-0200-02
PUMP KIT, CADD-SOLIS HPCA, MDL 2100, GERMAN 1/EA
21-2101-0200-03
PUMP KIT, CADD-SOLIS HPCA, MDL 2100, ITALIAN 1/EA
21-2101-02 |
|---|
| Code Information |
All CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps
UDI-DI:
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
04546027095903
04546027095910
04546027422983
04546027424116
04546027424130
04546027424147
04546027424178
04546027424185
04546027424192
04546027424208
04546027424598
05019517154934
05019517155108
10610586031854
10610586033933
10610586033940
10610586035067
10610586035357
10610586035395
10610586035401
10610586035418
10610586035432
10610586035456
10610586035494
10610586038501
10610586038518
10610586038792
10610586038839
10610586038860
10610586038891
10610586038914
10610586038921
10610586038938
10610586038952
10610586038969
10610586038983
10610586038990
10610586039010
10610586039041
10610586039065
10610586039072
10610586039089
10610586039195
10610586039256
10610586039270
10610586039409
10610586039416
10610586039430
10610586039447
10610586039454
10610586039461
10610586039478
10610586039485
10610586039492
10610586040429
10610586040443
10610586040528
10610586041822
10610586042607
10610586042614
10610586042843
15019517084382
15019517084399
15019517084405
15019517084412
15019517084429
15019517084443
15019517084450
15019517084467
15019517086720
15019517149517
15019517149975
15019517150025
15019517150032
15019517150049
15019517150056
15019517150063
15019517150070
15019517150087
15019517150094
15019517150100
15019517150117
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
|
| FEI Number |
3012307300
|
Recalling Firm/
Manufacturer |
Smiths Medical ASD, Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
|
| For Additional Information Contact | Technical Support
800-241-4002 |
|---|
Manufacturer Reason
for Recall | 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. |
|---|
FDA Determined
Cause 2 | Labeling design |
|---|
| Action | On April 10, 2025, the firm notified affected consignees via letters titled "Urgent Medical Device Correction."
Customers were informed of conditions under which the false Upstream Occlusion Alarm may occur. The USO alarm can be cleared during these conditions by removing the administration from the pump, re-attaching the administration set, and restarting delivery. Customers should verify there is no upstream occlusion present.
The firm will be making an update to the Infusion Pump Operator's Manual to include these conditions.
|
|---|
| Quantity in Commerce | 185,975 US; 127,701 OUS Total |
|---|
| Distribution | Worldwide - US nationwide distribution. |
|---|
| 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 = MEA
510(K)s with Product Code = MEA
510(K)s with Product Code = MEA
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