Recall of Regard Sterile C Section Packs Due to Glove Splitting Risk
Resource Optimization & Innovation Llc is recalling 670 sterile C Section Packs because a light glove component can split, potentially 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 and involves a risk of breaking the sterile field, which poses a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 670 units of Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis. These custom procedure trays were distributed to facilities in Louisiana and Texas. The affected lots have expiration dates ranging from July 13, 2017, to May 10, 2018.
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 should stop using these specific procedure trays and contact the manufacturer for further instructions. The FDA has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 670
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)
- 026385D Exp Date 2017-07-13
- 028105D Exp Date 2017-09-14
- 029774D Exp Date 2017-12-04
- 031980D Exp Date 2018-03-02
- 033476D Exp Date 2018-05-10
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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