The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is designed to reduce bleeding at implant and thereby eliminates the operative preclotting
Check against the official notice below — it lists the full affected range.
Getinge US Sales LLC is recalling one unit of a vascular graft product due to a packaging error. The product shipped was a HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft with a diameter size of 16 x 9 mm, but the carton was labeled as containing a HEMASHIELD PLATINUM Woven Double Velour Vascular Graft with a diameter size of 16 x 8 mm. The affected product has Lot Code 18K31, Serial Number 1190443415, and Part Number M00202166168P0, and was distributed in New Jersey.
The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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).
Reason for recall: 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). Distribution: US state of NJ Quantity: 1 unit Lot/code info: Lot Code: 18K31 Serial Number: 1190443415 Part Number: M00202166168P0 UDI Code: 00384401018452
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.