FDAFDA · Food and drugs·Recall number Z-1063-2014
Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.
Published February 26, 2014 · Recall initiated: January 29, 2014
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
Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766 because it may not satisfy customer requirements for the robustness of the Velcro closure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Implantech Associates Inc
- Distributor
- Worldwide Distribution - USA (nationwide) in the states of: CA, AZ, IL, NC, CO and the country of: South Africa.
- Lot
- Catalog Number SLV634, Lot Number 852766.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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