Covidien recalls Surgiwand II suction devices due to particulate matter in tubing from damaged Y-connector during assembly. Affected models include 178083, 178093, 178094.
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.
Covidien is recalling Surgiwand II suction and irrigation devices because a damaged Y-connector during assembly creates particulate matter inside the tubing. This could pose a risk to patients during surgery if particles enter the surgical site.
The Y-connector component can become damaged during assembly, generating small particles that may enter the surgical site. This particulate matter could potentially cause complications during surgery if it enters the patient's body.
Healthcare professionals using the Surgiwand II device for surgery are most at risk. Patients undergoing procedures with this device may be exposed to particulate matter.
Check for product numbers 178083, 178093, or 178094. The device has a UDI-Device Identifier (GTIN/UPN) listed as 10884523000887, 20884523000884, 10884523000900, 20884523000907, 10884523000917, or 20884523000914.
Verify if your device has product numbers 178083, 178093, or 178094.
The recall is due to particulate matter in the tubing caused by a damaged Y-connector during assembly.
Product numbers 178083, 178093, and 178094 are affected.
Check for product numbers 178083, 178093, or 178094 on the device label.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1411-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1411-2021 from Covidien. 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.
