Suture retention devices recalled with no reason stated in FDA record
DRS Vascular is recalling 264 Q-Stop Suture Retention Devices. The FDA enforcement record for this action carries a placeholder in place of a stated reason for the recall.
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: Rubric level 2 covers voluntary precautionary recalls; the FDA record states no hazard at all, so there is no basis in the source for scoring this higher.
Plain-English summary
The Q-Stop Suture Retention Device, catalog number QS, made by DRS Vascular, Inc. of San Jose, California, is being recalled. The device is described as a sterile, single-use, lightweight appliance made of biocompatible materials that can be installed within minutes to assist with venous access hemostasis. The affected product carries lot code 00860011629405 for the 6-pack and 10860011629402 as the unit of use. The recall covers 264 units distributed in Arkansas, California and New York.
The action is a voluntary, firm-initiated recall and the FDA classified it as Class II. The reason field in the FDA enforcement record for this recall contains the placeholder text "XXX" rather than a description, so the published record does not state why the product was recalled. Nothing further should be read into that absence.
Hospitals and clinics holding these lot codes should follow the manufacturer's instructions and contact DRS Vascular for details of the affected product.
The recalled product
- Product
- Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily…
- Manufacturer
- Drs Vascular, Inc
- Category
- Medical Device — Vascular Access
- Affected units
- 264
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 (1)
- Lot Code: 00860011629405 (6-pack) Unit of use: 10860011629402
Distribution
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