Recall record at a glance
| Official record | Z-1821-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Unomedical As |
| Report date | Jul 1, 2015 |
| Recall initiation date | May 21, 2015 |
| Quantity | 22,976,870 units |
| Location | Roskilde, Denmark |
Official product description
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
Why the product was recalled
Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.
Distribution information
Worldwide Distribution -- US, including the states of CA, IL, MN, and PA; and, the countries of Australia, Bahrain, Belgium, Canada, China, Cypress, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Kuwait, Lebanon, Malaysia, Maldives, Oman, Schweiz, South Africa, Spain, Sweden, Switzerland, Netherlands, Turkey, United Arab Emirates, and United Kingdom.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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