Recall record at a glance
| Official record | Z-1851-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Teleflex Medical |
| Report date | Jul 2, 2014 |
| Recall initiation date | May 23, 2014 |
| Quantity | 1658 ea |
| Location | Research Triangle Park, NC, United States |
Official product description
RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.
Why the product was recalled
Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the accompanying caution statement "Caution: This product contains Natural Rubber Latex which may cause Allergic Reactions" was not printed on the product label.
Distribution information
Nationwide Distribution and the country of Colombia.
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.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.