🔍 RecallPedia

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

Class I - Dangerous
🏥 Medical Devices Recalled: February 14, 2025 Smiths Medical ASD Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI 30610586038444 Lots WW8214 022980-1-22 022404-1-17 021860-1-10 021110-1-7 020609-1-2 016288-1-1 022980-1-24 022404-1-18 021860-1-14 021110-1-8 020609-1-3 017774-1-1 022980-1-23 022404-1-19 021860-1-13 021110-1-9 020609-1-4 018139-1-1 022980-1-26 022404-1-20 021860-1-15 021110-1-10 020609-1-5 018184-1-1 022980-1-27 022404-1-21 021860-1-17 021110-1-11 020609-1-6 018252-1-1 022980-1-28 022404-1-22 021860-1-16 021110-1-12 020609-1-7 018458-1-1 022980-1-25 022404-1-23 021860-1-18 021110-1-13 020609-1-8 018457-1-1 022980-1-32 022404-1-24 021860-1-20 021110-1-14 020609-1-9 018614-1-1 022980-1-30 022404-1-25 021860-1-21 021110-1-16 020609-1-10 018641-1-1 022980-1-29 022404-1-26 021860-1-19 021110-1-15 020609-1-11 018789-1-1 022980-1-31 022404-2-2 021860-2-1 021110-1-17 020609-1-12 018789-2-1 022980-1-33 022404-1-27 021860-2-2 021110-1-18 020609-1-13 018789-3-1 023592-1-3 022404-2-1 021860-1-22 021110-1-19 020609-1-14 018789-4-1 023592-1-2 022404-2-3 021860-2-5 021110-1-20 020609-1-15 018936-1-1 023592-1-1 022404-2-4 021860-2-3 021110-1-21 020609-1-16 018936-2-1 023592-1-5 022404-2-5 021860-2-4 021110-1-22 020609-1-19 018936-3-1 023592-1-6 022404-2-6 021860-2-6 021110-1-23 020609-1-20 018936-4-1 023592-1-4 022404-2-7 021860-2-8 021110-1-24 020609-1-17 019179-1-1 023592-1-7 022404-2-8 021860-2-7 021110-1-25 020609-1-21 019254-1-1 023592-1-9 022404-2-9 021860-2-10 021110-1-26 020609-1-18 019323-1-1 023592-1-8 022404-2-10 021860-2-11 021110-1-27 020609-1-23 019383-1-1 023592-1-12 022404-2-11 021860-2-9 021110-1-28 020609-1-22 019409-1-1 023592-1-11 022404-2-12 021860-2-12 021110-1-29 020609-1-24 019410-1-1 023592-1-10 022404-2-13 021860-2-13 021110-1-30 020609-1-26 019549-1-1 023592-1-15 022980-1-3 021860-2-14 021110-1-33 020609-1-27 019613-1-1 023592-1-16 022980-1-1 021860-2-15 021110-1-31 020609-1-25 019671-1-1 023592-1-17 022980-1-2 021860-2-16 021110-1-34 020609-1-28 019747-1-1 023592-1-18 022980-1-4 021860-2-17 021110-1-35 020609-1-30 019782-1-1 023592-1-19 022980-1-5 021860-2-18 021110-1-32 020609-1-31 019810-1-1 023592-1-20 022980-1-6 022404-1-2 021110-1-36 020609-1-29 019920-1-1 9755313 022980-1-7 022404-1-1 021110-1-37 020609-1-34 019974-1-1 9755312 022980-1-8 022404-1-3 021110-1-38 020609-1-32 020000-1-1 9757103 022980-1-10 022404-1-4 021110-1-39 020609-1-33 020022-1-1 9757119 022980-1-11 022404-1-5 021110-1-40 020609-1-35 020022-2-1 9755311 022980-1-9 022404-1-6 021860-1-3 020609-1-36 020074-1-1 9759068 022980-1-12 022404-1-7 021860-1-4 020609-1-37 020126-1-1 9757614 022980-1-13 022404-1-8 021860-1-2 020609-1-38 020127-1-1 9761695 022980-1-15 022404-1-9 021860-1-1 020609-1-39 020159-1-1 9760404 022980-1-14 022404-1-10 021860-1-5 020609-1-40 020160-1-1 9762385 022980-1-16 022404-1-11 021860-1-7 021110-1-1 020227-1-1 9759947 022980-1-17 022404-1-12 021860-1-6 021110-1-2 020323-1-1 9759328 022980-1-18 022404-1-13 021860-1-11 021110-1-3 020346-1-1 9762393 022980-1-19 022404-1-14 021860-1-8 021110-1-4 020386-1-1 9763712 022980-1-20 022404-1-15 021860-1-9 021110-1-5 020435-1-1 9763703 022980-1-21 022404-1-16 021860-1-12 021110-1-6 020466-1-1 020609-1-1 020561-1-1 020551-1-1 020505-1-1 /
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Smiths Medical ASD, Inc.
Reason for Recall:
Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

Product Codes/Lot Numbers:

UDI-DI 30610586038444 Lots WW8214 022980-1-22 022404-1-17 021860-1-10 021110-1-7 020609-1-2 016288-1-1 022980-1-24 022404-1-18 021860-1-14 021110-1-8 020609-1-3 017774-1-1 022980-1-23 022404-1-19 021860-1-13 021110-1-9 020609-1-4 018139-1-1 022980-1-26 022404-1-20 021860-1-15 021110-1-10 020609-1-5 018184-1-1 022980-1-27 022404-1-21 021860-1-17 021110-1-11 020609-1-6 018252-1-1 022980-1-28 022404-1-22 021860-1-16 021110-1-12 020609-1-7 018458-1-1 022980-1-25 022404-1-23 021860-1-18 021110-1-13 020609-1-8 018457-1-1 022980-1-32 022404-1-24 021860-1-20 021110-1-14 020609-1-9 018614-1-1 022980-1-30 022404-1-25 021860-1-21 021110-1-16 020609-1-10 018641-1-1 022980-1-29 022404-1-26 021860-1-19 021110-1-15 020609-1-11 018789-1-1 022980-1-31 022404-2-2 021860-2-1 021110-1-17 020609-1-12 018789-2-1 022980-1-33 022404-1-27 021860-2-2 021110-1-18 020609-1-13 018789-3-1 023592-1-3 022404-2-1 021860-1-22 021110-1-19 020609-1-14 018789-4-1 023592-1-2 022404-2-3 021860-2-5 021110-1-20 020609-1-15 018936-1-1 023592-1-1 022404-2-4 021860-2-3 021110-1-21 020609-1-16 018936-2-1 023592-1-5 022404-2-5 021860-2-4 021110-1-22 020609-1-19 018936-3-1 023592-1-6 022404-2-6 021860-2-6 021110-1-23 020609-1-20 018936-4-1 023592-1-4 022404-2-7 021860-2-8 021110-1-24 020609-1-17 019179-1-1 023592-1-7 022404-2-8 021860-2-7 021110-1-25 020609-1-21 019254-1-1 023592-1-9 022404-2-9 021860-2-10 021110-1-26 020609-1-18 019323-1-1 023592-1-8 022404-2-10 021860-2-11 021110-1-27 020609-1-23 019383-1-1 023592-1-12 022404-2-11 021860-2-9 021110-1-28 020609-1-22 019409-1-1 023592-1-11 022404-2-12 021860-2-12 021110-1-29 020609-1-24 019410-1-1 023592-1-10 022404-2-13 021860-2-13 021110-1-30 020609-1-26 019549-1-1 023592-1-15 022980-1-3 021860-2-14 021110-1-33 020609-1-27 019613-1-1 023592-1-16 022980-1-1 021860-2-15 021110-1-31 020609-1-25 019671-1-1 023592-1-17 022980-1-2 021860-2-16 021110-1-34 020609-1-28 019747-1-1 023592-1-18 022980-1-4 021860-2-17 021110-1-35 020609-1-30 019782-1-1 023592-1-19 022980-1-5 021860-2-18 021110-1-32 020609-1-31 019810-1-1 023592-1-20 022980-1-6 022404-1-2 021110-1-36 020609-1-29 019920-1-1 9755313 022980-1-7 022404-1-1 021110-1-37 020609-1-34 019974-1-1 9755312 022980-1-8 022404-1-3 021110-1-38 020609-1-32 020000-1-1 9757103 022980-1-10 022404-1-4 021110-1-39 020609-1-33 020022-1-1 9757119 022980-1-11 022404-1-5 021110-1-40 020609-1-35 020022-2-1 9755311 022980-1-9 022404-1-6 021860-1-3 020609-1-36 020074-1-1 9759068 022980-1-12 022404-1-7 021860-1-4 020609-1-37 020126-1-1 9757614 022980-1-13 022404-1-8 021860-1-2 020609-1-38 020127-1-1 9761695 022980-1-15 022404-1-9 021860-1-1 020609-1-39 020159-1-1 9760404 022980-1-14 022404-1-10 021860-1-5 020609-1-40 020160-1-1 9762385 022980-1-16 022404-1-11 021860-1-7 021110-1-1 020227-1-1 9759947 022980-1-17 022404-1-12 021860-1-6 021110-1-2 020323-1-1 9759328 022980-1-18 022404-1-13 021860-1-11 021110-1-3 020346-1-1 9762393 022980-1-19 022404-1-14 021860-1-8 021110-1-4 020386-1-1 9763712 022980-1-20 022404-1-15 021860-1-9 021110-1-5 020435-1-1 9763703 022980-1-21 022404-1-16 021860-1-12 021110-1-6 020466-1-1 020609-1-1 020561-1-1 020551-1-1 020505-1-1 /

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1405-2025

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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

Smiths Medical ASD

Class I - Dangerous

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Apr 10, 2025 Infusion Pumps Nationwide View Details →

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Smiths Medical ASD

Class I - Dangerous

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Smiths Medical ASD

Class I - Dangerous

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

Apr 10, 2025 Infusion Pumps Nationwide View Details →