Recall record at a glance
| Official record | Z-0080-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Baxter Healthcare Corp |
| Report date | Oct 22, 2014 |
| Recall initiation date | Oct 17, 2013 |
| Quantity | 3,085,080 |
| Location | Deerfield, IL, United States |
Official product description
15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
Why the product was recalled
The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage.
Distribution information
Worldwide Distribution - US Nationwide (including Puerto Rico) and countries of, Canada, Australia, New Zealand, Thailand, Malaysia, Singapore, Korea, Japan, Philippines, Columbia, Ecuador, Austria, Bahran, Belgium, Bosnia & Herzegovina, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Ireland, Isreal, Italy, Jordan, Kazakhstan, Latvia, Luxembourg, Malta, Norway, Oman, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovakia, South Africa, Spain (including Canary Islands), Sweden, Switzerland, The Netherlands, Turkey and United Arad Emirates.
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.