Recall of Regard Sterile Laparotomy Kits Due to Glove Splitting Risk
Resource Optimization & Innovation LLC is recalling 78 sterile laparotomy kits because a light glove component may 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 risk-of-harm product (sterile field breach) where injury has not yet been reported, fitting the High severity criteria for medical devices with potential for significant harm but no confirmed adverse events.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 78 units of Regard, Item Number: 880342003, Sterile, GS0776C - Laparotomy - OSU kits. The affected kits have a code of 035171C and an expiration date of 2018-07-14. These kits were distributed in the United States to locations in Louisiana and Texas.
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.
Healthcare facilities that have received these kits should stop using them immediately and contact the recalling firm for instructions on return or disposal. No specific instructions for individual consumers are provided as these are professional medical devices.
The recalled product
- Product
- Regard, Item Number: 880342003, Sterile, GS0776C - Laparotomy - OSU
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 78
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)
- 035171C Exp Date 2018-07-14
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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