Vascutek Gelseal Vascular Grafts Recalled for Incorrect Length Labeling
Vascutek, Ltd. is recalling 12 Gelseal vascular grafts labeled as 30cm but actually 15cm. The devices were distributed in Michigan and four other countries.
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 minor labeling error regarding product dimensions, with no reported injuries or illnesses in the source text.
Plain-English summary
Vascutek, Ltd. is recalling 12 units of Gelseal Straight Diameter 8mm Length 15cm vascular graft prostheses. The recall is due to a labeling error where the product was labeled as a 30cm graft, but the graft inside the box was actually a 15cm graft.
The affected devices are identified by Product Code 431508, Batch 301509/01, and Serial Numbers 0001515180 through 0001515191. These devices were distributed in the state of Michigan (USA), and the countries of the United Kingdom, Australia, Poland, and Germany.
Vascular graft prostheses are implanted devices intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. The source text does not specify instructions for consumers or healthcare providers regarding the handling of these specific units.
The recalled product
- Product
- Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
- Manufacturer
- Vascutek, Ltd.
- Category
- Medical Device — Vascular Graft
- Hazard
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- Product Code 431508
- Batch 301509/01
- Serial Numbers 0001515180
- 0001515181
- 0001515182
- 0001515183
- 0001515184
- 0001515185
- 0001515186
- 0001515187
- 0001515188
- 0001515189
- 0001515190
- 0001515191
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Vascutek, Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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