Recall of Spohn Shoulder System Kits Due to Glove Splitting Risk
Resource Optimization & Innovation LLC is recalling 382 sterile Spohn Shoulder System kits because a light glove component can split during application, 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 where a defect can break the sterile field, posing a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 382 sterile Spohn Shoulder System kits (Item Number: 800415002, OR0484B). The affected lots have expiration dates of December 9, 2017, January 14, 2018, and April 21, 2018. These kits were distributed in the United States to locations in Louisiana and Texas.
The recall was initiated because the kits 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 and consumers who have these specific kits should stop using them immediately. The manufacturer is responsible for the recall and should be contacted for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Regard, Item Number: 800415002, Sterile, OR0484B- Shoulder System Pk - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 382
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 (3)
- 029920B Exp Date 2017-12-09
- 030885B Exp Date 2018-01-14
- 033055B Exp Date 2018-04-21
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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