Recall of Regard Sterile Breast PK Procedure Trays Due to Glove Defect
Resource Optimization & Innovation Llc is recalling 14 kits of Regard sterile breast PK procedure trays because a light glove component can split during use, 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 defect that breaks the sterile field, creating a risk of infection or harm. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 14 kits of Regard, Item Number: 880321003, Sterile, GS0752C - Breast PK - OSU. The recall involves custom procedure trays distributed to locations in Louisiana and Texas. The affected lots have expiration dates of 2017-09-30.
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 sterile medical procedures.
Healthcare facilities and consumers who have these specific procedure trays should stop using them immediately. The source text does not specify a contact number or return instructions, so users should refer to the official FDA recall notice for further guidance on disposal or return.
The recalled product
- Product
- Regard, Item Number: 880321003, Sterile, GS0752C - Breast PK - OSU
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 14
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)
- 030874C Exp Date 2017-09-30
- 032520C 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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