Recall of Regard Sterile Custom Procedure Trays Due to Glove Defect
Resource Optimization & Innovation LLC is recalling 209 sterile custom 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 other harm during surgery. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 209 units of Regard sterile custom procedure trays, Item Number 800550001. These trays are designated for hip and shoulder procedures and were distributed to Medical Center Santa Rosa in California 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.
Healthcare facilities that have received these trays should stop using them immediately and contact the recalling firm for instructions on return or disposal. The affected lots have expiration dates ranging from March 2017 to March 2018.
The recalled product
- Product
- Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 209
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 (6)
- 027181A Exp Date 2017-03-30
- 030175A Exp Date 2017-03-30
- 030570A Exp Date 2017-11-30
- 031809A Exp Date 2017-12-30
- 032419A Exp Date 2018-03-25
- 033639A Exp Date 2018-03-30
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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