Recall of Regard Vascular Procedure Trays Due to Glove Splitting Risk
Resource Optimization & Innovation LLC is recalling 164 sterile vascular procedure trays because a light glove component may split during use, breaking the sterile field.
What this means for you
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 involves a medical device defect that breaks the sterile field, creating a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 164 kits of Regard, Item Number 800413005, Sterile, CV0482E- Vascular PK - Spohn. The recall affects specific lots with expiration dates of September 15, 2018, and November 12, 2018. These products were distributed in the United States to locations in California and Texas.
The recall was initiated because the trays contain a light glove component that can split during application to a light handle. This defect can break the sterile field, which is a critical safety requirement for surgical procedures.
Healthcare facilities that have received these specific trays should stop using them and contact the recalling firm for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 164
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 (2)
- 038155E Exp Date 2018-09-15
- 039572E Exp Date 2018-11-12
Distribution
Part of a larger recall action
This product is one of 135 recalled by Resource Optimization & Innovation Llc 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.
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