FDA Recall Terminated

Custom surgical kits: DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.02, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 surgical kits

Recall: Z-1003-2012 · Initiated January 10, 2012

Recall

Recall Number: Z-1003-2012
Event Number: 61038
FEI Number: 1000208624
Product Code: LRP
Status: Terminated
Root Cause: Nonconforming Material/Component
Initiated: January 10, 2012
Posted: February 13, 2012
Terminated: November 5, 2012
Address: 1703 Highway 33 S, DeRoyal Processing Center, New Tazewell, TN, 37825-5043

Description

Reason

The firm distributed surgical kits which contained DermaHook Neuro Elastic Retractors which were subsequently recalled by Teleflex.

Action

DeRoyal Industries sent a Customer letter dated January 6, 2012, to the affected customer. The letter identified the product the problem and the action needed to be taken by the customer. An email was also sent on January 10, 2012, to the affected customer. The customer was requested to follow these instructions. 1) Identify any affected inventory using the product and lot numbers on Attachment 1. 2) Attach the provided warning label to each affected kit and tray. 3) Forward this recall to any of your end users that may have affected product. 4) Complete and return Attachment 1 by fax (865-362-3716) or email ([email protected]) within two weeks of the date of this letter, even if you no longer have affected inventory. If you have questions or need assistance with the recall, including additional labels, please call (865) 362-1037 . We apologize for any inconvenience this may caused you.

Distribution

(USA) including Indiana

Quantity

214 units