Recall of Pacemaker Procedure Trays Due to Light Glove Splitting
Resource Optimization & Innovation LLC is recalling 26 sterile pacemaker procedure trays because the included light gloves 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 26 sterile pacemaker procedure trays (Item Number: 880328002, HT0759B). The affected lots have expiration dates of 2018-05-12 and 2018-07-21. These trays were distributed to locations in Louisiana and Texas.
The recall was initiated because the trays contain a component, a light glove, that can split during application to a light handle. This splitting can break the sterile field, which is a critical safety requirement for surgical procedures.
Healthcare facilities that have received these specific trays should stop using them and contact the recalling firm for instructions on return or disposal. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 26
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)
- 037932B Exp Date 2018-05-12
- 039334B Exp Date 2018-07-21
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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