Getinge Recalls One Vascular Graft Due to Incorrect Packaging Label
Getinge is recalling one HEMASHIELD GOLD vascular graft that was incorrectly packed in a carton labeled for a HEMASHIELD PLATINUM graft.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a packaging/labeling error where a product was packed in the wrong carton. No injuries or illnesses are reported, and the hazard is limited to potential confusion during selection rather than a direct safety defect in the device itself.
Plain-English summary
Getinge US Sales LLC is recalling one unit of the HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft. The product has a diameter size of 16 x 9 mm. The recall was initiated after an internal incident report identified that this specific unit was likely incorrectly packed inside a carton labeled to contain a HEMASHIELD PLATINUM Woven Double Velour Vascular Graft with a diameter size of 16 x 8 mm.
The affected product is identified by the following codes: Part Number M00202166168P0, Lot 18K31, and Serial Number 1190443415. The distribution pattern for this recall is limited to the US state of New Jersey.
Healthcare providers and facilities should check their inventory for this specific serial number and part number. If the product is found, it should be removed from use and returned to Getinge US Sales LLC according to their instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- 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…
- Manufacturer
- GETINGE US SALES LLC
- Category
- Medical Device — Vascular Graft
- Affected units
- 1
Distribution
Distributed in 1 state:
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