FDAFDA · Food and drugs·Recall number Z-1134-2014
DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
Published March 12, 2014 · Recall initiated: January 16, 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
Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DeRoyal Industries Inc
- Distributor
- US Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS.
- Lot
- lot numbers 33347799, 33444071, and 33423747
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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