Recall of Sterile Laparotomy Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 248 sterile laparotomy 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 medical device defect that breaks the sterile field, creating a risk of infection or harm during surgery, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 248 kits of Regard sterile laparotomy procedure trays (Item Number: 880342002, GS0776B). The affected trays were distributed in the United States to locations in Louisiana and Texas. The recall involves specific lots with expiration dates ranging from May 2017 to January 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 that have received these trays should stop using them and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- Regard, Item Number: 880342002, Sterile, GS0776B - Laparotomy - OSU
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 248
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)
- 027338B Exp Date 2017-05-30
- 027664B Exp Date 2017-06-30
- 028391B Exp Date 2017-07-30
- 028752B Exp Date 2017-07-30
- 029416B Exp Date 2017-09-30
- 030580B Exp Date 2017-10-30
- 032134B Exp Date 2018-01-30
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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