Recall of Regard Custom Procedure Trays Due to Light Glove Splitting
Resource Optimization & Innovation LLC is recalling 356 Regard custom procedure trays 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 is classified as FDA Class II. The hazard involves breaking the sterile field, which poses a risk of harm (infection) but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 356 kits of Regard custom procedure trays (Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa). The recall involves specific lots with expiration dates ranging from August 24, 2017, to July 11, 2018.
The recall was initiated because the trays contain a light glove component that can split during application to a light handle. This failure breaks the sterile field, which is a critical safety requirement for medical procedures.
The affected products were distributed in the United States to locations in California and Texas. Healthcare facilities and consumers who possess these specific trays should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 356
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)
- 027750A Exp Date 2017-08-24
- 028676A Exp Date 2017-10-13
- 029916A Exp Date 2017-12-08
- 030661A Exp Date 2018-01-04
- 034835A Exp Date 2018-07-11
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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