Resource Optimization & Innovation Recalls Sterile Breast PK Procedure Trays
Resource Optimization & Innovation Llc is recalling 16 sterile breast PK 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 is classified as FDA Class II and involves a risk-of-harm product (sterile field breach) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 16 sterile procedure kits identified as Regard, Item Number: 880321002, GS0752B - Breast PK - OSU. The recall involves specific lots with expiration dates of September 30, 2017, and codes 029000B and 029744B. The products were distributed in the United States to locations in Louisiana and Texas.
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. The agency has classified this as a Class II recall.
Healthcare facilities and consumers who have these specific procedure trays should stop using them immediately. Users should contact the recalling firm, Resource Optimization & Innovation Llc, for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Regard, Item Number: 880321002, Sterile, GS0752B - Breast PK - OSU
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 16
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)
- 029000B Exp Date 2017-09-30
- 029744B Exp Date 2017-09-30
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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