Recall record at a glance
| Official record | Z-0835-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Stryker Corporation |
| Report date | Mar 14, 2018 |
| Recall initiation date | Nov 17, 2017 |
| Quantity | 60,753 units total |
| Location | San Jose, CA, United States |
Official product description
StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip (Model 0250070520) STRYKER LAPAROSCOPIC SUCTION IRRIGATOR
Why the product was recalled
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Distribution information
Distributed domestically to . Distributed internationally to Australia and Mexico.
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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