Recall of Regard Sterile C Section Packs Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 320 sterile C Section Packs 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 sterile medical device where a defect (glove splitting) breaks the sterile field. This creates a risk of harm (infection) even though no specific injuries are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 320 units of Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St Francis. The affected products are sterile procedure trays distributed in the United States to locations in Louisiana and Texas. The recall involves specific lots with expiration dates of August 5, 2018, September 19, 2018, and December 14, 2018.
The recall was initiated because the trays contain a light glove component that can split during application to a light handle. This splitting action breaks the sterile field, which is a critical safety requirement for surgical and sterile procedures. The manufacturer identified the defect and is recalling the product to prevent potential contamination or infection risks associated with a compromised sterile environment.
Healthcare facilities and consumers who have these specific procedure trays should stop using them immediately. Users should check their inventory for the item number 800036005 and the specific expiration dates listed above. If the product is found, it should be quarantined and returned to the distributor or manufacturer according to their instructions.
The recalled product
- Product
- Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St Francis
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 320
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 (3)
- 037143E Exp Date 2018-08-05
- 038259E Exp Date 2018-09-19
- 040326E Exp Date 2018-12-14
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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