Getinge recalls specific HEMASHIELD Platinum Vascular Grafts (Lot 18K31, SN 1190443415) due to possible incorrect packing. This may lead to improper use in medical procedures.
Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft product with the diameter size of 16 x 9 mm is likely incorrectly packed inside of the carton which was labeled to contain a HEMASHIELD PLATINUM Woven Double Velour Vascular Graft product with the diameter size of 16 x 8 mm ((REF: M00202166168P0, Lot: 18K31, SN: 1190443415, size 16 x 8 mm).
Getinge is recalling a specific model of vascular grafts that may have been incorrectly packed. This could lead to improper use during medical procedures if the wrong size graft is used.
The recall involves a specific graft model that was likely incorrectly packed. This could result in the wrong size graft being used during surgery, potentially causing improper medical procedures.
Medical professionals who use the HEMASHIELD Platinum Vascular Grafts with Lot Code 18K31 and Serial Number 1190443415 are most at risk. Patients receiving these grafts during surgery may be affected.
Check for Lot Code 18K31 and Serial Number 1190443415 on the product packaging. The product is labeled as HEMASHIELD PLATINUM Woven Double Velour Vascular Graft with size 16 x 8 mm.
Verify the Lot Code (18K31) and Serial Number (1190443415) on the product packaging.
The recall is due to an internal incident report indicating that the specific HEMASHIELD Platinum Vascular Graft model with Lot Code 18K31 and Serial Number 1190443415 may have been incorrectly packed.
The risk is that the wrong size graft could be used during surgery, potentially leading to improper medical procedures.
Check for Lot Code 18K31 and Serial Number 1190443415 on the product packaging. The product is labeled as HEMASHIELD PLATINUM Woven Double Velour Vascular Graft with size 16 x 8 mm.
We’ve drafted a message you can send Getinge to request your refund or repair — edit it as you like.
Subject: Recall Z-2559-2019 — Getinge Getinge Hello, I own a Getinge that is covered by recall Z-2559-2019 from Getinge. 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.