FDA Recalls 170 Sterile Laparoscopic Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 170 sterile laparoscopic procedure trays because a light glove component can split during application, breaking the sterile field.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant risk of harm (breaking the sterile field in a surgical setting) corresponds to a severity score of 4 (Severe).
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 170 kits of Regard sterile laparoscopic procedure trays (Item Number: 880341003, GS0775C - Laparoscopic - OSU). The recall was initiated by the manufacturer, Resource Optimization & Innovation LLC, due to a defect in a light glove component included in the trays.
The light glove can split during application to a light handle. This failure breaks the sterile field, which is a critical safety requirement for surgical procedures. The affected products were distributed in the United States to locations in Louisiana and Texas. The specific code for the affected units is 037275C with an expiration date of August 3, 2018.
Healthcare facilities and consumers who have these specific procedure trays should stop using them immediately. They should contact the recalling firm, Resource Optimization & Innovation LLC, for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Regard, Item Number: 880341003, Sterile, GS0775C - Laparoscopic - OSU
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 170
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)
- 037275C Exp Date 2018-08-03
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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