Recall of Sterile Lap Chole Procedure Kits Due to Glove Splitting
Resource Optimization & Innovation Llc is recalling 420 sterile lap chole procedure 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 risk-of-harm product where the defect (breaking the sterile field) poses a significant risk of infection, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 420 units of the Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover Hills. These custom procedure trays were distributed to locations in Louisiana and Texas. The affected lots have expiration dates of May 10, 2018, and July 12, 2018.
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 and consumers who have these specific procedure kits should stop using them immediately and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover Hills
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 420
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)
- 033493D Exp Date 2018-05-10
- 035015D Exp Date 2018-07-12
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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