Reported Apr 21, 2021 · Ongoing
Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product…
Covidien
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: Covidien · 201 Sabanetas Industrial Park · Ponce, PR · 00716
Is this the product you have?
- Covidien Surgiwand"
- II Suction and Irrigation DeviceElectrosurgical, cutting & coagulation &
- accessories22 Product Number/CFN
178083178093178094
- Lot codes and dates
- UDI-Device Identifier (GTIN/UPN)
1088452300088720884523000884
- UDI-Device Identifier (GTIN/UPN)
1088452300090020884523000907
- UDI-Device Identifier (GTIN/UPN)
1088452300091720884523000914
- UDI-Device Identifier (GTIN/UPN)
- Amount recalled
- 59,828 devices
Where it was sold
Why it was recalled
Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector.
This product could cause temporary or reversible health problems — stop using it.
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