FDA-Device2014-03-12Class II

DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.

DeRoyal Industries Inc
Hazard

Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely.

Sold states
US Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS.
Affected count
2504 units
Manufactured in
200 Debusk Ln, Powell, TN, United States
Products
DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1134-2014

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