Recall of Pacemaker Procedure Kits Due to Defective Light Gloves
Resource Optimization & Innovation LLC is recalling 28 sterile pacemaker procedure kits 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 28 sterile pacemaker procedure kits (Item Number: 880328001) due to a defect in a component. The kits contain a light glove that has been recalled by the manufacturer because it can split during application to a light handle.
This defect can break the sterile field during the procedure. The affected product is identified by the following codes: 031483A (Expiration Date 2017-02-27) and 034832A (Expiration Date 2017-12-03). The product was distributed to locations in Louisiana and Texas.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice. No illnesses or injuries are reported in the source text.
The recalled product
- Product
- Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 28
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)
- 031483A Exp Date 2017-02-27
- 034832A Exp Date 2017-12-03
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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