Recall of Regard Sterile Lap PK Spohn Custom Procedure Trays
Resource Optimization & Innovation LLC is recalling 3,000 sterile custom 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, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 3,000 kits of Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - Spohn custom procedure trays. The affected lots have expiration dates ranging from June 21, 2018, to November 9, 2018. The product was distributed in the United States to locations in California and Texas.
The recall was initiated because the trays contain a light glove component that has been recalled by the manufacturer. This component can split during application to a light handle, which breaks the sterile field. The source text does not report any illnesses or injuries associated with this defect.
Healthcare facilities should stop using the affected trays and contact the recalling firm for instructions on return or disposal. Consumers are not expected to have this product in their homes, as it is a medical device distributed to professional facilities.
The recalled product
- Product
- Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 3,000
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)
- 034435B Exp Date 2018-6-21
- 037051B Exp Date 2018-6-21
- 037462B Exp Date 2018-07-29
- 038293B Exp Date 2018-08-17
- 038779B Exp Date 2018-09-21
- 039465B Exp Date 2018-10-10
- 040093B Exp Date 2018-11-09
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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