Elevated risk U.S. Food and Drug Administration

Smith’s Medical Cadd Infusion System Infusion Sets for use with Cadd pumps recall: Potential lack of delivery or underdelivery and false no disposable attached

Recall published 3+ years ago

Potential lack of delivery or underdelivery and false no disposable attached (NDA) alarms.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: The first issue, lack of delivery or under delivery, may occur due to manufacturing variations that can potentially cause the green CADD Flow Stop arm to compress partially occlude the tubing before clinical use.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Published
December 12, 2022
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Smith’s Medical
Product type
Medical devices

Products covered by this recall

CADD Infusion System Infusion Sets for use with CADD pumps

What the company announced

MINNEAPOLIS, Dec. 12, 2022 /PRNewswire/ -- Smiths Medical issued an Urgent Medical Device Correction Letter to notify affected customers of two potential issues with CADDTM Infusion System Infusion Sets related to potential lack of delivery or under delivery and false no disposable attached (NOA) alarms. The letter details the issues, the affected items, the required steps to perform, and specific instructions for treatment of patients requiring life sustaining therapy.

The first issue, lack of delivery or under delivery, may occur due to manufacturing variations that can potentially cause the green CADD Flow Stop arm to compress partially occlude the tubing before clinical use. If this happens, there is a potential that the occlusion does not resolve when the CADD reservoir or administration set is connected to the pump, and the pump may not detect the occlusion. This may result in under delivery or non-delivery of medication, despite the pump displaying that the infusion is running properly.

The second issue, false "no disposable attached" (NOA) alarms, is specific to CADD-Legacy pumps, which Smiths Medical announced the discontinuation of sale effective December 31, 2022. There is a potential that CADD-Legacy pumps may not detect that 50 ml and 700 ml CADD Medication Cassette Reservoirs with Flow Stop are attached to the pump when they are properly attached. When this happens, the pump will initiate an NOA alarm if the NOA double-beep warning is not resolved within 2 minutes. The user must clear the alarm and resolve the cause of the NOA event before using the pump. This issue does not impact 250 ml Flow-Stop and non-Flow Stop CADD Medication Cassette Reservoirs.

A copy of the customer notification, which outlines the potential risks associated with both under delivery and NDA alarms, lists the affected products, and provides specific actions users should take in the event of such occurrences, can be found here.

For further inquiries, please contact Smith Medical using the information provided below.

  • Smiths Medical Contact: Global Complaint Management · Contact Information: [email protected] 1-(866)-216-8806 · Areas of Support: To report adverse events or product complaints
  • Smiths Medical Contact: Technical Assistance · Contact Information: 1-(800)-258-5361 · Areas of Support: Additional information or technical assistance

The U.S. Food and Drug Administration (FDA) has been notified of this action.

If you wish to contact the FDA regarding any adverse events or quality problems associated with this notice, use the following contact information.

www.fda.gov/medwatch

1-(888)-1NFO-FDA

Media Contact:

Tom McCall

949-366-4368

[email protected]

SOURCE ICU Medical, Inc.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Package size

Match the net weight or the piece count on the front of the pack.

  • 50 ml
  • 700 ml
  • 250 ml

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Smith’s Medical — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Smith’s Medical — Media: Tom McCall, 949-366-4368, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Smith’s Medical medical devices recalled?

Potential lack of delivery or underdelivery and false no disposable attached (NDA) alarms. The first issue, lack of delivery or under delivery, may occur due to manufacturing variations that can potentially cause the green CADD Flow Stop arm to compress partially occlude the tubing before clinical use.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

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