Z-2891-2011

DeRoyal (R) Incision and Drainage Tray, RES 47-763.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries...

Name: Z-2891-2011 DeRoyal (R) Incision and Drainage Tray, RES 47-763.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries...
Creator: Deroyal Industries, Inc. Lafollette
Published: 2011-04-28
License: https://open.fda.gov/license/

Deroyal Industries, Inc. Lafollette / initiated 2011-04-28 / Terminated

FDA source

Deroyal Industries, Inc. Lafollette began a recall of DeRoyal (R) Incision and Drainage Tray, RES 47-763.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot... on 2011-04-28. The reason FDA records is "Custom surgical kits contain recalled Triad PVP prep pads". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2891-2011
Status: Terminated
Initiated: 2011-04-28
Posted: 2011-07-28
Terminated: 2014-08-07
Recalling firm: Deroyal Industries, Inc. Lafollette
Product: DeRoyal (R) Incision and Drainage Tray, RES 47-763.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Numbers: 20641391, 21092240, 21950988, 22594153, 22739623, 22773346, 23068497, 23098901, 23435082, 24203902, 24725655, 24781729, 24901874, 25403527 DeRoyal (R) Incision and Drainage Tray, RES 47-773, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Numbers: 20432290, 20605752, 20922248, 21092178, 22615161, 23231338, 23567595, 24526171, 24781745 DeRoyal (R) Incision and Drainage Tray, OCEAN SPRINGS HOSP, RES 50-12437.08, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Numbers: 22871229, 23187891, 23282362, 23335049, 23693022, 24004508, 24289321, 24599046, 24853850, 25159510, 25609040, 20675048, 20886013, 21316397, 21529982, 21861715, 22203984, 22412903, 22729708, 22799765 DeRoyal (R) Incision and Drainage Tray, ST JOSEPHS HOSPITAL, RES 89-6818.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Numbers: 23606275, 23941604, 24336115, 24867670, 25220026, 25324301, 25814617, 21364022, 21372541, 21420961, 21469650, 21527602, 21641296 DeRoyal (R) Universal Insertion Tray, RES 89-5649.01, ST FRANCIS MED CAPE GIRARDEAU, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Numbers: 22981727, 23234934, 21320071, 21374634, 21651531, 21817255, 22019861, 22187911, 22588503, 21651531 DeRoyal (R) St. Suture Removal Kit, RES 32-1695, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA, made in Dominican Republic Lot Numbers: 20170218, 21096486, 21114411, 21242931, 21331394, 21344427, 21381711, 23683529, 23767212, 23883758 DeRoyal (R) Stainless Suture Removal Set, RES 32-351, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA, made in Dominican Republic Lot Numbers: 20188629, 20738627, 20838062, 21114437, 21410754, 21667171, 21790558, 22052557, 22389467, 22572739, 22865427, 23169950, 23452384, 23627906, 23883820, 24255913, 24408502, 24957430 DeRoyal (R) CRICOTHYREOTOMY AMBULANCE KIT, WISHARD MEMORIAL HOSPITAL, RES 89-6752.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Numbers: 20835339, 21511803, 23485821 DeRoyal (R) DR MATA'S PLASTIC PACK, OUR LADY OF LOURDES, RES 89-7212.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Numbers: 22408453, 22653627, 22718814, 22777961, 23218782, 23942181, 24285119, 24571254, 24597462, 25414921, 25527677, 25646027, 25683611, 25744313, 25744321 Custom Surgical kits.
Product code: LRP Tray, Surgical
Reason for recall: Custom surgical kits contain recalled Triad PVP prep pads
FDA root cause: Other
Action: DeRoyal sent a Customer letter dated July 6, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. The customer was instructed to reference the attached spreadsheet to identify your accounts kits/trays and the corresponding lot numbers affected by this recall. Please complete and return the Acknowledgement Form by fax ( 865-362-3716) confirming you have been notified of this action. For further questions, please call ( 865) 362-2334.
Quantity in commerce: 11,856 kits/trays
Distribution: Nationwide Distribution--including the states of CA, FL,GA, HI, IL, IN, LA, MA, MO, MS, NY, PA, and RI.
Product codes and lots: RES 47-763.02, Lot Numbers: 20641391, 21092240, 21950988, 22594153, 22739623, 22773346, 23068497, 23098901, 23435082, 24203902, 24725655, 24781729, 24901874, 25403527 RES 47-773, Lot Numbers: 20432290, 20605752, 20922248, 21092178, 22615161, 23231338, 23567595, 24526171, 24781745 RES 50-12437.08, Lot Numbers: 22871229, 23187891, 23282362, 23335049, 23693022, 24004508, 24289321, 24599046, 24853850, 25159510, 25609040, 20675048, 20886013, 21316397, 21529982, 21861715, 22203984, 22412903, 22729708, 22799765 RES 89-6818.01, Lot Numbers: 23606275, 23941604, 24336115, 24867670, 25220026, 25324301, 25814617, 21364022, 21372541, 21420961, 21469650, 21527602, 21641296 RES 89-5649.01, Lot Numbers: 22981727, 23234934, 21320071, 21374634, 21651531, 21817255, 22019861, 22187911, 22588503, 21651531 RES 32-1695, Lot Numbers: 20170218, 21096486, 21114411, 21242931, 21331394, 21344427, 21381711, 23683529, 23767212, 23883758 RES 32-351, Lot Numbers: 20188629, 20738627, 20838062, 21114437, 21410754, 21667171, 21790558, 22052557, 22389467, 22572739, 22865427, 23169950, 23452384, 23627906, 23883820, 24255913, 24408502, 24957430 RES 89-6752.01, Lot Numbers: 20835339, 21511803, 23485821 RES 89-7212.01, Lot Numbers: 22408453, 22653627, 22718814, 22777961, 23218782, 23942181, 24285119, 24571254, 24597462, 25414921, 25527677, 25646027, 25683611, 25744313, 25744321

Product code LRP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)