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Terminated

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

FDA Recall Z-3254-2011 · Posted 2011-09-16

Recalling FirmDeroyal Industries, Inc. Lafollette
Recall StatusTerminated
Product CodeHFX
Date Initiated2011-05-05
Date Terminated2013-01-30
Product Quantity390 units

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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