FDA Recall Terminated

DeRoyal (R) ST. Circumcision Clamp, REF 32-1622, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Circumcision Clamp

Recall: Z-3253-2011 · Initiated May 5, 2011

Recall

Recall Number
Z-3253-2011
Event Number
59770
Firm
Deroyal Industries, Inc. Lafollette
FEI Number
3005011024
Product Code
HFX
Status
Terminated
Root Cause
Other
Initiated
May 5, 2011
Posted
September 16, 2011
Terminated
January 30, 2013
Address
1501 East Central Ave La, Follette, TN, 37766-2892

Description

DeRoyal (R) ST. Circumcision Clamp, REF 32-1622, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Circumcision Clamp

Reason

The firm distributed surgical kits which contained circumcision clamps that were subsequently recalled by Surgical Design.

Action

DeRoyal Industries, Inc. sent a recall notification letter dated 05/05/2011. A second notice was sent on 07/26/2011 to affected customers who did not respond to the initial notice. Questions regarding this recall may contact the Corporate Attorney at (865) 362-1037.

Distribution

USA (nationwide) including the states of AR, AZ, FL, GA, LA, MI, NJ, NM, and OH.

Quantity

100 units