Terumo Recalls Mislabelled Vascutek Gelsoft Vascular Grafts
Terumo CVS is recalling nine Vascutek Gelsoft vascular grafts because they were incorrectly labeled with the wrong diameter.
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 the hazard is a labeling error (mis-labeling) rather than a structural defect or contamination, fitting the criteria for moderate severity.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling nine units of the Vascutek Gelsoft Vascular Graft (peripheral). The specific units involved are catalog number 631508, with serial numbers ranging from 0001765391 to 0001765399. These devices are gelatin-sealed, woven polyester grafts indicated for abdominal and peripheral vascular repair.
The recall was initiated after a customer complaint indicated that a 15mm x 8mm Gelsoft graft was received, but the customer believed it was a 15mm x 6mm unit. The manufacturer confirmed that a batch of product code 631508 was incorrectly labeled. The affected units were distributed in the United States to the states of North Carolina and California.
Healthcare providers and patients should check their inventory and records for these specific serial numbers. If these units are found, they should be removed from use and returned to the manufacturer according to the recall instructions.
The recalled product
- Product
- Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diameter 8mm***Usable Length 15cm***Manufactured By***VASCUTEK Ltd. a TERUMO Company Newmains Avenue…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Vascular Graft
- Hazard
- Affected units
- 9
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 (9)
- Catalog Number 631508 Serial Numbers: 0001765391
- 0001765392
- 0001765393
- 0001765394
- 0001765395
- 0001765396
- 0001765397
- 0001765398
- 0001765399
Distribution
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