FDAFDA · Food and drugs·Recall number Z-1657-2017
Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn
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
- 026440A Exp Date 2017-07-16; 030021A Exp Date 2017-12-11; 030186A Exp Date 2017-12-21; 031464A Exp Date 2018-02-15; 032390A Exp Date 2018-03-22; 033782A Exp Date 2018-05-20
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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