Recall of Regard Sterile Abdominal PK Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation Llc is recalling 290 sterile abdominal 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 and involves a risk of harm (breaking the sterile field) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 290 units of Regard, Item Number: 800533003 Sterile, GS0606C - Abdominal PK - Westover Hills. The recall involves specific lots with expiration dates of 2018-08-30 and 2018-11-07. These products were distributed to locations in Louisiana and Texas.
The recall is being issued 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 sterile medical procedures.
Healthcare facilities and consumers who have these specific procedure trays should stop using them immediately and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 800533003 Sterile, GS0606C - Abdominal PK - Westover Hills
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 290
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 (2)
- 037810C Exp Date 2018-08-30
- 039435C Exp Date 2018-11-07
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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