Bolton Medical recalls TREO Abdominal Stent-Graft System implants with potential incorrect size matching carton labels. Affected units include specific GTINs and catalog numbers. No remedy stated in official notice.
Potential for the incorrect size stent-graft than the printed carton label.
Bolton Medical is recalling its TREO Abdominal Stent-Graft System implants due to a risk that the actual size might differ from what's printed on the carton label. This could lead to improper placement during medical procedures. The recall covers specific product variants with detailed catalog numbers and GTINs.
The hazard involves the possibility that the stent-graft's actual size may not match the label on the carton. If the size is incorrect, it could lead to improper placement during aneurysm repair, potentially causing complications or failure of the procedure.
Patients who have received the TREO Abdominal Stent-Graft System implants from Bolton Medical are likely affected. Medical professionals using these implants for aneurysm repair are at risk if they have the recalled products.
Check the GTIN number and catalog number on the product packaging. Affected units include specific GTINs and catalog numbers listed in the recall notice, such as 00843576151963 and 28-S2-13-080U.
Review the GTIN number and catalog number on the product packaging to determine if it matches the listed affected units in the recall notice.
The recall states there is a potential for the incorrect size stent-graft compared to the printed carton label, but no specific harm has been reported. The official notice does not state the remedy or confirm injuries.
The official recall notice does not specify a remedy. Check the GTIN and catalog numbers on the product packaging to see if it matches the affected units listed in the recall.
Compare your product's GTIN number and catalog number with the specific affected units listed in the recall notice, such as 00843576151963 or 28-S2-13-080U.
We’ve drafted a message you can send Bolton Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1689-2023 — Bolton Medical Bolton Medical Hello, I own a Bolton Medical that is covered by recall Z-1689-2023 from Bolton Medical. 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.
