Recall record at a glance
| Official record | Z-1351-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Outset Medical, Inc. |
| Report date | Apr 19, 2023 |
| Recall initiation date | Jan 24, 2023 |
| Quantity | 374 systems |
| Location | San Jose, CA, United States |
Official product description
Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility.
Why the product was recalled
An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.
Distribution information
U.S. Nationwide distribution including in the states of AK, AL, AR, CA, CO, FL, GA, HI, IA, ID, IL, IN, MI, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, and WI. O.U.S.: Not provided.
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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