Recall of Regard Sterile Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation Llc is recalling 88 kits of Regard sterile procedure trays because a light glove component can split during application, 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 where a defect breaks the sterile field, creating a risk of infection or harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 88 kits of Regard sterile procedure trays (Item Number: 800091002, LD0692B - C Section - FMOL Lady of Angels). The recall is due to a defect in a light glove component included in the trays.
The light glove can split during application to a light handle, which breaks the sterile field. This defect compromises the sterility of the procedure tray. The affected units were distributed in the United States to locations in California (LA) and Texas (TX).
The affected lots have expiration dates ranging from July 20, 2017, to May 13, 2018. Specific lot codes include 026556B, 029081B, 031679B, 032434B, and 033616B. Users should stop using these trays and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of Angels
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 88
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 (5)
- 026556B Exp Date 2017-07-20
- 029081B Exp Date 2017-10-23
- 031679B Exp Date 2018-02-19
- 032434B Exp Date 2018-03-24
- 033616B Exp Date 2018-05-13
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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