Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa Rosa
Reported: April 5, 2017 Initiated: January 9, 2017 #Z-1611-2017
Product Description
Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa Rosa
Reason for Recall
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
Details
- Recalling Firm
- Resource Optimization & Innovation Llc
- Units Affected
- 100 kits
- Distribution
- US Distribution to LA and TX.
- Location
- Springfield, MO
Frequently Asked Questions
What product was recalled? ▼
Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa Rosa. Recalled by Resource Optimization & Innovation Llc. Units affected: 100 kits.
Why was this product recalled? ▼
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 5, 2017. Severity: Moderate. Recall number: Z-1611-2017.
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