FDA Recalls Robotic Hysterectomy Kits Due to Sterile Field Breach Risk
Resource Optimization & Innovation LLC is recalling 288 robotic hysterectomy kits because a light glove component can split, 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. The hazard involves breaking the sterile field, which poses a risk of infection, but the source text does not report any hospitalizations, serious injuries, or deaths, aligning with the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 288 kits of Regard Robotic Hysterectomy Pk - Spohn (Item Number: 800416001). The recall is being conducted by Resource Optimization & Innovation LLC. The affected kits were distributed in the United States to locations in Louisiana and Texas.
The recall is necessary because the custom procedure trays contain a light glove component that has been recalled by the manufacturer. This component can split during application to a light handle, which breaks the sterile field. The affected lots have expiration dates ranging from October 16, 2017, to March 2, 2018.
Healthcare facilities and consumers who possess these specific kits should stop using them immediately. The recall is classified as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 288
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 (4)
- 028912A Exp Date 2017-10-16
- 030725A Exp Date 2018-01-08
- 031994A Exp Date 2018-03-02
- 033625A Exp Date 2018-02-20
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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