Recall of Robotic Hysterectomy Kits Due to Light Glove Splitting
Resource Optimization & Innovation LLC is recalling 249 sterile 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 involves a medical device where a defect can break the sterile field, posing a risk of harm (infection) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 249 units of the Regard Robotic Hysterectomy Pk (Item Number: 800416002, Sterile, GY0485B - Spohn). The recall involves specific lots with expiration dates of July 13, 2018, September 22, 2018, and November 12, 2018.
The recall was initiated because the kits 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. The affected products were distributed in the United States to locations in Louisiana and Texas.
Healthcare facilities and consumers who possess these specific kits should stop using them immediately. The manufacturer is responsible for the recall and should be contacted for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 249
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 (3)
- 035084B Exp Date 2018-07-13
- 038325B Exp Date 2018-09-22
- 039576B 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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