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Accu-Chek Solo Cannula Assembly & Pump Holder and Accu-Chek Solo Supply Kit

Publié le: 23 décembre 2022ID du rappel: 8a0612cf-cfec-42f3-a4a1-339f2a0cab38Catégorie: Produits de ConsommationPays: Australie
Australia
Safety AlertAustralia ProductsAustraliaAustralia

Accu-Chek Solo Cannula Assembly & Pump Holder and Accu-Chek Solo Supply Kit

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Traduire l’alerteTranslate notice text, hazard warnings, and descriptions into any supported language.

Motif du rappel / Danger

Insulin leakage has occurred with the Accu-Chek Solo Cannula Assembly and Pump Holder. If the insulin leakage is not immediately noticed when using the Accu-Chek Solo system this could potentially lead to an under-delivery of insulin.

Description du produit & Identification

Reason / Defects: Insulin leakage has occurred with the Accu-Chek Solo Cannula Assembly and Pump Holder. If the insulin leakage is not immediately noticed when using the Accu-Chek Solo system this could potentially lead to an under-delivery of insulin. Hazards: If insulin is under-delivered, this may lead to adverse health events including severe hyperglycaemia or the user may experience diabetic ketoacidosis (DKA) and may require hospitalisation or intervention from a medical professional. What to do: Consumers should check whether they have an affected product and if so stop using them. Consumers should contact Roche Diabetes Customer Care to make arrangements to receive a replacement. For more details see https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01541-1 For further information, please contact Roche Diabetes Customer Care by phone on 1800 251 516.

Produits concernés

Accu-Chek Solo Cannula Assembly & Pump Holder (9 mm; 10+3 & 6 mm; 10+3) and Accu-Chek Solo Supply Kit (9 mm) & (6 mm) Cannula lot numbers: 847468303 and lower Reference numbers: 07858833001, 07858841001, 07858817001 & 07858825001 ARTG 308704 (Roche Diabetes Care Australia Pty Ltd - Insulin infusion patch pump administration set) ARTG 311432 (Roche Diabetes Care Australia Pty Ltd - Ambulatory insulin infusion administration set/reservoir kit)

Additional Source Details

FieldValue
Guid › #text8a0612cf-cfec-42f3-a4a1-339f2a0cab38
Guid › @ is Perma Linkfalse
Linkhttps://www.productsafety.gov.au/search-consumer-product-recalls/accu-chek-solo-cannula-assembly-pump-holder-and-accu-chek-solo-supply-kit
Pub DateFri, 23 Dec 2022 00:00:00 +0000

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Check the model number, serial number, and date stamp on the rating label on the back or underside of the product.

2Isolate & Discontinue Use

Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (Australia Products).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Accu-Chek Solo Cannula Assembly & Pump Holder and Accu-Chek Solo Supply Kit?

Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (Australia Products). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Aperçu

  • Niveau de risquePharmacy and medical products
  • DistributionAustralia
Recall Hazard Severity
Caution (Class III)
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