FDAFDA · Food and drugs·Recall number Z-1608-2017
Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa Rosa
Published April 5, 2017 · Recall initiated: January 9, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Resource Optimization & Innovation Llc
- Distributor
- US Distribution to LA and TX.
- Lot
- 027181A Exp Date 2017-03-30; 030175A Exp Date 2017-03-30; 030570A Exp Date 2017-11-30; 031809A Exp Date 2017-12-30; 032419A Exp Date 2018-03-25; 033639A Exp Date 2018-03-30;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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