FDA Device Recall Z-0966-2023

Smiths Medical ASD Inc. · Minneapolis, MN

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24, 13) REF 21-7349-24, 14) REF 21-7359-24, 15) REF 21-7363-24, 16) REF 21-7383-24, 17) REF 21-7391-24, 18) REF 21-7394-24, 19) REF 21-7600-24, 20) REF 21-7609-24, 21) REF 21-7624-24, 22) REF 21-7649-24, 23) REF 21-7301-24JP, 24) REF 21-7302-24JP, 25) REF 21-7308-24JP, 26) REF 21-7309-24JP, 27) REF 21-7322-24JP, 28) REF 21-7359-24JP, 29) REF 21-7394-24JP, 30) REF 21-7600-24JP, 31) REF 21-7609-24JP, 32) REF 21-7624-24JP, 33) REF 21-7649-24JP. Computerized Ambulatory Delivery Device

Lot / serial / GTIN: 1) REF 21-7300-24, UDI/DI 30610586027196, Lot Number: 3630772 through 4334107; 2) REF 21-7301-24, UDI/DI 30610586027219, Lot numbers: 3630747 through 4334119; 3) REF 21-7302-24, UDI/DI 30610586027233, Lot numbers: 3617363 through 4334138; 4) REF 21-7308-24, UDI/DI 30610586032374, Lot numbers: 4053922 through 4334076; 5) REF 21-7309-24, UDI/DU 30610586032381, Lot numbers: 4062405 though 4334085; 6) REF 21-7310-24, UDI/DU 30610586032398, Lot numbers: 4062404 through 4330874; 7) REF 21-7322-24, UDI/DI 30610586029640, Lot numbers: 3776375 through 4334324; 8) REF 21-7323-24, UDI/DI 30610586039618, Lot numbers: 3776373 through 4334325; 9) REF 21-7324-24, UDI/DI 30610586029657, Lot numbers: 3773527 through 4334328; 10) REF 21-7333-24, UDI/DI 30610586043233, Lot numbers: 3776362 through 3984144; 11) REF 21-7343-24, UDI/DI 35019517191824, Lot numbers: 3965344 through 4334338; 12) REF 21-7346-24, UDI/DI 35019517161957, Lot numbers: 3776356 through 4320785; 13) REF 21-7349-24, UDI/DI 35019517184239, Lot numbers: 3926579 through 4339160; 14) REF 21-7359-24, UDI/DI 30610586027400, Lot numbers: 3776315 through 4334339; 15) REF 21-7363-24, UDI/DI 35019517161964, Lot numbers: 3773412 through 4334343; 16) REF 21-7383-24, UDI/DI 30610586027479, Lot numbers: 3780549 through 3971523; 17) REF 21-7391-24, UDI/DI 30610586027516, Lot numbers: 3773276 through 4334351; 18) REF 21-7394-24, UDI/DI 30610586027530, Lot number: 3774739 through 4339178; 19) REF 21-7600-24, UDI/DI 30610586044001, Lot numbers: 4084914 through 4329633; 20) REF 21-7609-24, UDI/DI 30610586044018, Lot Numbers: 4072200 through 4334090; 21) REF 21-7624-24, UDI/DI 30610586044742, Lot numbers: 4092506 through 4309481; 22) REF 21-7649-24, UDI/DI 35019517184246, Lot numbers: 4076410 through 4334357. 23) REF 21-7301-24JP, UDI/DI N/A, Lot Numbers: 3630747 through 4334113; 24) REF 21-7302-24JP, UDI/DI N/A, Lot Numbers: 3617363 through 4329630; 25) REF 21-7308-24JP, UDI/DI N/A, Lot Numbers: 4053922 through 4334075; 26) REF 21-7309-24JP, UDI/DI N/A, Lot Numbers: 4062405 through 4330870; 27) REF 21-7322-24JP, UDI/DI N/A, Lot Numbers: 3776375 through 4334324; 28) REF 21-7359-24JP, UDI/DI N/A, Lot Numbers: 3776315 through 4334339; 29) REF 21-7394-24JP, UDI/DI N/A, Lot Numbers: 3774739 through 4339178; 30) REF 21-7600-24JP, UDI/DI N/A, Lot Numbers: 4084914 through 4329633; 31) REF 21-7609-24JP, UDI/DI N/A, Lot Numbers: 4072200 through 4334090; 32) REF 21-7624-24JP, UDI/DI N/A, Lot Numbers: 4092506 through 4309481; 33) REF 21-7649-24JP, UDI/DI N/A, Lot Numbers: 4076410 through 4334357.

Quantity: 47595495 units

Reason for recall

There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

Recall record

Recall number: Z-0966-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide Distribution: US (nationwide) and OUS countries of: CH, CA, ES, FR, AT, BE, IT, DK, NO, EE, DE, NL, AU, GB, SE, PL, SA, IN, IL, PT, CZ, IE, NZ, LU, SI, ZA, BM, SG, MQ, CL, LB, MY, HU, JP, TW, and CN
Recall initiated: 2022-12-09
Classified by FDA Center: 2023-01-30
FDA published: 2023-02-08
Recalling firm: Smiths Medical ASD Inc.
Firm location: Minneapolis, MN

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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