PlainRecalls
FDA Devices Critical Class I Ongoing

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

Reported: May 14, 2025 Initiated: April 10, 2025 #Z-1667-2025

Product Description

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

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.

Details

Recalling Firm
Smiths Medical ASD, Inc.
Units Affected
185,975 US; 127,701 OUS Total
Distribution
Worldwide - US nationwide distribution.
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
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. Recalled by Smiths Medical ASD, Inc.. Units affected: 185,975 US; 127,701 OUS Total.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 14, 2025. Severity: Critical. Recall number: Z-1667-2025.