FDA Recalls VenaSeal Vascular Closure Systems Due to Sterility Concerns
The FDA is recalling VenaSeal vascular closure systems because a possible sterility breach in the outer packaging may compromise the device's sterility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential sterility breach which could lead to infection, a risk-of-harm scenario where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the VenaSeal, Sapheon Closure System, manufactured by Covidien LLC. The recall affects Model # SP-101, VS-301, and VS-402, which are used for vascular procedures. A total of 1,661 units are involved in this recall.
The recall was initiated due to a possible sterility breach of the outer packaging (pouch) material. This defect may compromise the outside surface sterility of the sealed inner tray, posing a risk of infection if the device is used. The agency classifies this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The affected devices were distributed worldwide to Australia, Canada, France, Germany, Hong Kong, Ireland, Italy, Latvia, the Netherlands, Norway, Portugal, Switzerland, the UAE, and the United Kingdom. There are no U.S. accounts for this recall. Healthcare facilities and distributors should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
- Manufacturer
- Covidien LLC
- Affected units
- 1,661
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 (20)
- Model no. SP-101
- Lots
- 35766
- 36191
- 36192
- 36617
- 36618
- 37621
- 37622
- 37399
- 37400
- 38263
- 38286
- 38407
- 38417
- 38756
- 38863
- 38864
- 39113
- 39336
Distribution
Distribution scope not specified by the agency.
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