Resource Optimization Recalls Sterile Robotic Laparoscopic Procedure Trays
Resource Optimization & Innovation LLC is recalling 41 sterile robotic laparoscopic 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, fitting the High severity criteria.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 41 kits of Regard sterile robotic laparoscopic procedure trays (Item Number: 800599003, GS0694C). The affected products were distributed to facilities in Louisiana and Texas. The specific lots involved have expiration dates of August 5, 2018, and December 2, 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 surgical procedures.
Healthcare facilities should stop using the affected trays and contact the recalling firm for instructions on return or disposal. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Highland
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 41
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)
- 037222C Exp Date 2018-08-05
- 039975C Exp Date 2018-12-02
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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