Incisive Surgical recalls Insorb Subcutaneous Skin Stapper model REF 2030 due to possible sterile barrier compromise. Affected units include specific lot numbers and UDI codes.
Possible compromise of the sterile barrier integrity
Incisive Surgical is recalling its Insorb Subcutaneous Skin Stapper model REF 2:2030 because it might compromise sterile barrier integrity. This could lead to infections during medical procedures if the device is used without proper sterility.
The device's sterile barrier might not hold up properly during use, potentially allowing bacteria to enter the surgical site. This could lead to infections in patients during procedures.
Medical professionals using the Insorb Subcutaneous Skin Stapper for surgical procedures are most at risk. Patients undergoing surgery with this device could face infection risks if the sterile barrier is compromised.
Check for the model number REF 2030 on the device. Affected units have a specific lot number (182801) and UDI code (10867516000101).
Look for the model number REF 2030, lot number 182801, and UDI code 10867516000101 on the device.
The recall indicates a possible risk of sterile barrier compromise, so it is not recommended for use until the remedy is applied.
Check for the model number REF 2030, lot number 182801, and UDI code 10867516000101 on the device.
The recall does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send Incisive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0078-2019 — Incisive Surgical Incisive Surgical Hello, I own a Incisive Surgical that is covered by recall Z-0078-2019 from Incisive Surgical. 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.
