Recall of Sterile Arthroscopy Kits Due to Glove Splitting Risk
Resource Optimization & Innovation LLC is recalling 110 sterile arthroscopy kits 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 110 units of the Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn. The recall affects kits with expiration dates of 2018-01-22 (code 031160C) and 2018-04-12 (code 032881C). These products were distributed in the United States to locations in Louisiana and Texas.
The recall was initiated because the custom procedure trays contain a light glove component that can split during application to a light handle. This failure can break the sterile field, which is a critical safety requirement for surgical procedures.
Healthcare facilities and consumers who have these specific arthroscopy kits should stop using them immediately. The manufacturer is responsible for the recall of these 110 units.
The recalled product
- Product
- Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 110
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)
- 031160C Exp Date 2018-01-22
- 032881C Exp Date 2018-04-12
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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