Recall Z-3253-2011

Deroyal Industries, Inc. Lafollette · initiated May 5, 2011

Terminated

Product

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

Codes / lots: Lot Number 21989639

Reason for recall

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

FDA-determined cause: Other

Action taken

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.

Details

Recall number
Z-3253-2011
Initiated
May 5, 2011
Posted by FDA
September 16, 2011
Terminated
January 30, 2013
Product code
HFX – Clamp, Circumcision
Quantity
100 units
Distribution
USA (nationwide) including the states of AR, AZ, FL, GA, LA, MI, NJ, NM, and OH.
Recalling firm
Deroyal Industries, Inc. Lafollette, La Follette, TN

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-3254-2011 Circumcision trays and packs listed as follows: (1) DeRoyal (R) ST. Circumcision Tray…The firm distributed surgical kits which contained circumcision clamps that were subsequently recalled by… 05/05/2011Terminated