Recall of Spohn AV Access Procedure Kits Due to Glove Defect
Resource Optimization & Innovation LLC is recalling 118 Spohn AV Access Procedure Kits 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 is classified as FDA Class II, and the hazard involves breaking the sterile field, which poses a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 118 units of the Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn. The recall involves custom procedure trays that contain a light glove component. The affected lots have expiration dates of July 29, 2018, and November 15, 2018.
The recall was initiated because the light glove component can split during application to a light handle. This defect can break the sterile field, which is a critical safety requirement for sterile medical procedures. The agency has classified this as a Class II recall.
The products were distributed in the United States to locations in Louisiana and Texas. Healthcare facilities and consumers who have these specific kits should stop using them immediately and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 118
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)
- 037054B Exp Date 2018-07-29
- 039606B Exp Date 2018-11-15
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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