Recall of Regard Sterile Laparoscopic Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 704 sterile 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 704 kits of Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU. These custom procedure trays were distributed in the United States to locations in Louisiana and Texas.
The recall is being conducted 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.
The affected lots have expiration dates ranging from January 30, 2017, to April 30, 2018. Specific lot codes include 026598A, 028130A, 028918A, 029122A, 029906A, 031960A, and 033019A. Healthcare facilities should stop using these trays and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 704
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 (7)
- 026598A Exp Date 2017-06-30
- 028130A Exp Date 2017-07-30
- 028918A Exp Date 2017-01-30
- 029122A Exp Date 2017-09-30
- 029906A Exp Date 2017-10-30
- 031960A Exp Date 2018-01-30
- 033019A Exp Date 2018-04-30
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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