Recall record at a glance
| Official record | Z-2735-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Medtronic Perfusion Systems |
| Report date | Sep 16, 2015 |
| Recall initiation date | Aug 18, 2015 |
| Quantity | 1594 total (1306 US, 288 OUS) |
| Location | Brooklyn Park, MN, United States |
Official product description
MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status.
Why the product was recalled
Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic Perfusion Tubing packs.
Distribution information
Worldwide Distribution-US (nationwide) including the states of AL, AR, CA, CO, FL, HI, ID, IN, KS, LA, MA, MS, MO, NY, NJ, OH, PA, TN, TX, UT, and WI, and the countries of Bolivia, Denmark, Dominican Republic, Italy, Latvia, Lebanon, Mexico, Panama, Singapore, Venezuela, and Zambia.
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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