FDAFDA · Food and drugs·Recall number Z-1598-2017
Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills
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
- 027929B Exp Date 2017-08-30; 029240B Exp Date 2017-09-30; 030080B Exp Date 2017-10-30; 031818B Exp Date 2017-11-30;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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