Recall of Custom Procedure Trays with Defective Light Gloves
Resource Optimization & Innovation LLC is recalling 384 custom procedure trays because the included light gloves 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 medical device defect that breaks the sterile field, creating a risk of harm (infection) even though no injuries have been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 384 custom procedure trays, identified by Item Number 800560002 and described as 'Regard, Sterile, GS0649B - Lap Chole - Childrens Santa Rosa'. The affected trays were distributed to locations in California and Texas.
The recall was initiated because the trays contain a component, a light glove, that has been recalled by the manufacturer. This specific component can split during application to a light handle, which breaks the sterile field. The source text does not report any illnesses or injuries associated with this defect.
Healthcare facilities should stop using the affected trays and contact the recalling firm for instructions on return or disposal. The affected lots have expiration dates ranging from October 2017 to May 2018.
The recalled product
- Product
- Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 384
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 (4)
- 028898B Exp Date 2017-10-19
- 029882B Exp Date 2017-10-19
- 031071B Exp Date 2018-01-25
- 033617B 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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