Recall of Regard Sterile Hip Shoulder Procedure Kits Due to Glove Defect
Resource Optimization & Innovation LLC is recalling 40 sterile 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 (sterile field breach) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 40 kits of Regard, Item Number: 800527003 Sterile, OR0611C - Hip Shoulder PK - Westover Hills. The affected lots have expiration dates of 2017-11-30 and 2017-12-30. The product was distributed in the United States to locations in Louisiana and Texas.
The recall was initiated because the custom procedure 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 that have received these specific kits should stop using them and contact the recalling firm for instructions on return or disposal. No illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Regard, Item Number: 800527003 Sterile, OR0611C - Hip Shoulder PK - Westover Hills
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 40
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)
- 031013C Exp Date 2017-11-30
- 031667C Exp Date 2017-12-30
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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