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.
What this means for you
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 op
- Manufacturer
- GETINGE US SALES LLC
- Category
- Medical Device — Vascular Graft
- Affected units
- 1
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · GETINGE US SALES LLC
See all →- HighGetinge Pediatric Diffusion Membrane Oxygenator Recalled for Sterility Concerns
FDA (Devices) · 2019-12-18
- LowGetinge CO2 Absorber Recalled for Reversed Expiration and Manufacturing Dates
FDA (Devices) · 2019-09-11
- ModerateGetinge Recalls Seven PulsioFlex Monitoring Systems Due to Error Messages
FDA (Devices) · 2019-07-31
- LowMaquet Edi Catheter Recalled for Incorrect Expiry Date Labeling
FDA (Devices) · 2019-05-01
- SevereMaquet XS Flat Screen Monitor Holder Recalled for Grounding Defect
FDA (Devices) · 2019-03-13
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02