Recall of Regard Sterile Abdominal PK Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation Llc is recalling 200 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 involves a risk-of-harm product (sterile field breach) where injury has not yet been reported, which aligns with the High severity criteria in the rubric.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 200 kits of Regard, Item Number: 800533002 Sterile, GS0606B - Abdominal PK - Westover Hills. The affected product is a custom procedure tray that includes a light glove component. The recall is limited to units with code 033472B and an expiration date of 2018-05-09.
The recall was initiated because the light glove component can split during application to a light handle. This failure breaks the sterile field, which is a critical safety requirement for sterile medical procedures.
The affected units were distributed in the United States to locations in Louisiana and Texas. The source text does not specify the number of reported injuries or illnesses associated with this defect.
The recalled product
- Product
- Regard, Item Number: 800533002 Sterile, GS0606B - Abdominal PK - Westover Hills
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 200
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 (1)
- 033472B Exp Date 2018-05-09
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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