Class I Recall

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,

Summary

The FDA issued a Class I for CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, by Smiths Medical ASD Inc.. Reason: There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) F.

Details

Source

Device Recall

External ID

Z-0966-2023

Action Date

2023-02-08

Status

Ongoing

Product Description

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/Code Info: 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 Affected: 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

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

Type: Voluntary: Firm initiated

Recall Initiated: 2022-12-09

Company

Smiths Medical ASD Inc.

Minneapolis, MN

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 122 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Smiths Medical ASD Inc. has 164 FDA actions in our database, including 162 recalls and 2 clearances.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Smiths Medical ASD Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Smiths Medical ASD Inc. have FDA actions?

Smiths Medical ASD Inc. has 164 FDA actions in our database, including 162 recalls and 2 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0966-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

Want to know the moment something like this happens?

Get alerts for device

Related Actions

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200

Covidien LP · 2023-08-23

Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO

MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15

VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri

Boston Scientific Corporation · 2024-09-25

EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo

Enchroma Inc · 2024-11-27

Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

Adept Medical Ltd · 2025-01-29