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Class 2 Device Recall Circumcision trays and packs |
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Date Initiated by Firm |
May 05, 2011 |
Date Posted |
September 16, 2011 |
Recall Status1 |
Terminated 3 on January 30, 2013 |
Recall Number |
Z-3254-2011 |
Recall Event ID |
59770 |
Product Classification |
clamp, circumcision - Product Code HFX
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Product |
Circumcision trays and packs listed as follows: (1) DeRoyal (R) ST. Circumcision Tray, REF 50-5613, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Made in Dominican Republic Lot Numbers: 20854003, 22892644 (2) DeRoyal (R) ST. Circumcision PACK 1.3 CLAMP CLAMPMEMORIAL HEALTH, MEMORIAL HOSP TAL WEST, REF 89-5699, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Number 20012949
Circumcision Clamp
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Code Information |
Lot Numbers: 20854003, 22892644, and 20012949 |
Recalling Firm/ Manufacturer |
Deroyal Industries, Inc. Lafollette 1501 East Central Ave La Follette TN 37766-2892
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For Additional Information Contact |
Tracy Edmundson 865-362-2334
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Manufacturer Reason for Recall |
The firm distributed surgical kits which contained circumcision clamps that were subsequently recalled by Surgical Design.
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FDA Determined Cause 2 |
Other |
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. |
Quantity in Commerce |
390 units |
Distribution |
USA (nationwide) including the states of AR, AZ, FL, GA, LA, MI, NJ, NM, and OH. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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