Stryker recalls specific lots of sterile cassette pumps and tube sets due to higher-than-acceptable bioburden levels. Affected units may pose infection risks during medical procedures.
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Stryker is recalling certain sterile cassette pumps and tube sets that tested with higher-than-acceptable bioburden levels. This could increase infection risk during medical procedures if used without proper sterilization.
Bioburden refers to the amount of microorganisms present in a sterile product. Higher levels than acceptable could lead to infections during medical procedures if the device isn't properly sterilized.
Healthcare professionals using these devices for medical procedures are most at risk. Patients receiving treatments with these devices may face infection risks.
Check for model numbers 0250070600 or 0250070620 on the packaging. Affected lots include specific UDI and lot numbers listed in the recall notice.
Look for model numbers 0250070600 or 0250070620 on the packaging or device.
Confirm if your unit has lot numbers 17284FG2, 17291FG2, 17300FG2, or other specific numbers listed in the recall.
Stryker found certain lots of these sterile cassette pumps and tube sets had higher-than-acceptable bioburden levels during routine testing.
Check for model numbers 0250070600 or 0250070620 and specific lot numbers listed in the recall notice.
The recall does not require immediate stop use; affected units should be checked for specific lot numbers and handled with caution.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0836-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0836-2018 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
