Approximately 6,300 units of High Flow Insufflation Tubing (with Filter) are being recalled because the packaging may have incomplete seals. This defect affects the Laparoscopic Insufflator model 20400161S with lot number 185198. Because the seals are incomplete, the device may no longer be sterile, which can lead to serious patient safety concerns during surgical procedures. These units were distributed in Massachusetts and have an expiration date of October 2028.
The incomplete packaging seals can allow contaminants to enter the device, rendering it non-sterile. Using a non-sterile insufflation tube during a laparoscopic procedure introduces bacteria directly into a patient's abdominal cavity, posing a high risk of infection or sepsis.
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If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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