Reported Apr 14, 2021 · Terminated
Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an…
Terumo Cardiovascular Systems Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Terumo Cardiovascular Systems Corporation · 125 Blue Ball Rd · Elkton, MD · 21921-5315
Is this the product you have?
- Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.
- Lot codes and dates
- GTIN Code(01)00699753450950
- Catalog NumberT401163
- Serial Numbers
T00393T00394T00395T00399T00403T00405T00406T00407T00408T00410T00411T00412
- Amount recalled
- 12
Where it was sold
Why it was recalled
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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