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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91392

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 09, 2022
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Smiths Medical ASD Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24

Z-0962-2023
Recall number
Z-0962-2023
Initiated
December 09, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
1616714 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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

Code information

a) REF 21-7346-24: UDI/DI 35019517161957; Lot Numbers: 3776356 through 4320785; b) REF 21-7363-24: UDI/DI 3501951716196; Lot Numbers: 3773412 through 4334343;

Distribution pattern

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

device · product 2 of 5

CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24, 13) REF 21-7359-24, 14) REF 21-7383-24, 15) REF 21-7390-24, 16) REF 21-7391-24, 17) REF 21-7394-24, 18) REF 21-7395-24, 19) REF 21-7301-24JP, 20) REF 21-7302-24JP, 21) REF 21-7321-24JP, 22) REF 21-7322-24JP, 23) REF 21-7359-24JP, 24) REF 21-7394-24JP

Z-0963-2023
Recall number
Z-0963-2023
Initiated
December 09, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
45285351 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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

Code information

1) REF 21-7300-24, UDI/DI 30610586027196, Lot numbers: 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 21-7321-24, UDI/DI 30610586029633, Lot numbers: 3773534 through 4308545; 5) REF 21-7322-24, UDI/DI 30610586029640, Lot numbers: 3776375 through 4334324; 6) REF 21-7323-24, UDI/DI 061058603961, Lot numbers: 3776373 through 4334325; 7) REF 21-7324-24, UDI/DI 30610586029657, Lot numbers: 3773527 through 4334328; 8) REF 21-7333-24, UDI/DI 30610586043233, Lot numbers: 3776362 through 3984144; 9) REF 21-7336-24, UDI/DI 30610586027295, Lot numbers: 3776360 through 4025381; 10) REF 21-7339-24, UDI/DI 30610586027301, Lot numbers: 3780565 through 4009665; 11) REF 21-7343-24, UDI/DI 35019517191824, Lot numbers: 3965344 through 4334338; 12) REF 21-7349-24, UDI/DI 35019517184239, Lot numbers: 3926579 through 4339160; 13) REF 21-7359-24, UDI/DI 30610586027400, Lot numbers: 3776315 through 4334339; 14) REF 21-7383-24, UDI/DI 30610586027479, Lot numbers: 3780549 through 3971523; 15) REF 21-7390-24, UDI/DI 30610586027509, Lot numbers: 3780548 through 4334346; 16) REF 21-7391-24, UDI/DI 30610586027516, Lot numbers: 3773276 through 4334351; 17) REF 21-7394-24, UDI/DI 30610586027530, Lot numbers: 3774739 through 4339178; 18) REF 21-7395-24, UDI/DI 30610586027547, Lot numbers: 3808536 through 4308562 19) REF 21-7301-24JP, UDI/DI N/A , Lot numbers: 3630747 through 4334113; 20) REF 21-7302-24JP, UDI/DI N/A , Lot numbers: 3617363 through 4329630; 21) REF 21-7321-24JP, UDI/DI N/A , Lot numbers: 3773534 through 4308545; 22) REF 21-7322-24JP, UDI/DI N/A , Lot numbers: 3776375 through 4334324; 23) REF 21-7359-24JP, UDI/DI N/A , Lot numbers: 3776315 through 4334339; 24) REF 21-7394-24JP, UDI/DI N/A , Lot numbers: 3774739 through 4339178.

Distribution pattern

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

device · product 3 of 5

CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Computerized Ambulatory Delivery Device

Z-0964-2023
Recall number
Z-0964-2023
Initiated
December 09, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
726,878 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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

Code information

a) REF 21-7308-24, UDI/DI 30610586032374, Lot Numbers: 4053922 through 4334076; b) REF 21-7309-24, UDI/DI 30610586032381, Lot Numbers: 4062405 through 4334085; c) REF 21-7310-24, UDI/DI 30610586032398, Lot Numbers: 4062404 through 4330874 d) REF 21-7308-24JP, UDI/DI N/A, Lot Numbers: 4053922 through 4334075; e) REF 21-7309-24JP, UDI/DI N/A, Lot Numbers: 4062405 through 4330870.

Distribution pattern

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

device · product 4 of 5

CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device

Z-0965-2023
Recall number
Z-0965-2023
Initiated
December 09, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
214668 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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

Code information

a) REF 21-7600-24, UDI/DI 30610586044001, Lot Numbers: 4084914 through 4329633; b) REF 21-7609-24, UDI/DI 30610586044018, Lot Numbers: 4072200 through 4334090; c) REF 21-7624-24, UDI/DI 30610586044742, Lot Numbers: 4092506 through 4309481; d) REF 21-7649-24, UDI/DI 35019517184246, Lot Numbers: 4076410 through 4334357; e) REF 21-7600-24JP, UDI/DI N/A, Lot Numbers: 4084914 through 4329633, f) REF 21-7609-24JP, UDI/DI N/A, Lot Numbers: 4072200 through 4334090; g) REF 21-7624-24JP, UDI/DI N/A, Lot Numbers: 4092506 through 4309481; h) REF 21-7649-24JP, UDI/DI N/A, Lot Numbers: 4076410 through 4334357.

Distribution pattern

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

device · product 5 of 5

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

Z-0966-2023
Recall number
Z-0966-2023
Initiated
December 09, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
47595495 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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

Code information

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.

Distribution pattern

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