Recall record at a glance
| Official record | Z-0117-2022 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Beckman Coulter Inc. |
| Report date | Oct 20, 2021 |
| Recall initiation date | Jul 28, 2021 |
| Quantity | Total Units=271 units [258 units (3K and 3K HS); 13 units (5K added 12/15/2021)] |
| Location | Brea, CA, United States |
Official product description
Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
Why the product was recalled
Missing splash guard which may expose users to hazardous materials. .
Distribution information
U.S. Nationwide Distribution in the states of: CA, GA, IA, ID, IL, IN, LA, MA, MI, MS, NJ, NY, OH, OR, PA, SC, SD, TN, TX, WA, and WV O.U.S.: Canada, China, Spain, France, United Kingdom, Israel, Italy, South Korea, Kuwait, Lebanon, Mexico, Malaysia, Netherlands, Portugal, Qatar, Saudi Arabia, Thailand, Turkey, and Taiwan. Additional O.U.S. added 12/15/2021 - South Africa
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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