New Wave Endo-Surgical recalls M-Close Kit REF 27-101 due to risk of plastic housing fracturing. Affected units have UDI/DI 00850009417022 and lot code C2020.
The plastic housing on the device may fracture
New Wave Endo-Surgical is recalling their M-Close Kit (REF 27-101) because the plastic housing might break. This could lead to injury during surgical procedures if the device fractures unexpectedly.
The plastic housing can fracture during use, potentially causing the device to malfunction. This could lead to complications during abdominal surgery if the device breaks unexpectedly.
Surgical teams using the M-Close Kit for abdominal procedures are most at risk. Patients undergoing surgery with this device may be affected if the housing fractures.
Check for the product name 'M-Close Kit' with reference number 27-101. Affected units have UDI/DI code 00850009417022 and lot code C2020.
Look for the UDI/DI code 00850009417022 and lot code C2020 on the device packaging.
The recall states the plastic housing may fracture, so it is not safe to use until the remedy is applied.
The recall does not specify a remedy, so contact New Wave Endo-Surgical directly for guidance.
Check for the UDI/DI code 00850009417022 and lot code C2020 on the device packaging.
We’ve drafted a message you can send New Wave Endo-Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1570-2023 — New Wave Endo-Surgical New Wave Endo-Surgical Hello, I own a New Wave Endo-Surgical that is covered by recall Z-1570-2023 from New Wave Endo-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.
