Recall Z-2086-2023

DeRoyal Industries Inc · initiated May 30, 2023

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) TOTAL KNEE PACK PGYBK, REF '89-10505; f) ANTERIOR HIP PACK PGYBK, REF '89-10563; g) ORTHO X-RAY PACK, REF '89-1495; h) GU PACK, REF '89-4479; i) BREAST PACK, REF '89-5424; j) SHOULDER ARTHROSCOPY PK, REF '89-6606; k) GYN PACK, REF '89-7369; l) ENT PACK, REF '89-7378; m) TOTAL HIP PACK PGYBK, REF '89-7540; n) EPIDURAL TRAY/CUSTOM, REF '89-8061; o) BREAST BIOPSY TRAY, REF '89-8187; p) BEACH CHAIR PACK, REF '89-8439; q) TOTAL KNEE PACK PGYBK, REF '89-8445; r) CYSTO PACK, REF '89-8482; s) SINGLE BASIN PLUS, REF '89-9131; t) TOTAL HIP PACK, REF '89-9287; u) ARTHROSCOPY PACK, REF '89-9626; v) SHOULDER PACK, REF '89-9632 CYSTO PACK, REF '89-10049 BEACH CHAIR SHOULDER PACK, REF '89-10721 EXTREMITY PACK, REF '89-10959 HYSTEROSCOPY PACK, REF '89-10960 VERITHENA VENOUS ABLATION PACK, REF '89-10977 CYSTO BASIN SET, REF '89-2577 OPEN HEART PACK, REF '89-8572 BACK PACK, REF '89-9292

Codes / lots: a) REF '53-1941, GTIN 50749756864676 (cs), 00749756864671 (unit), Lot Numbers: 59095817, 59108518, 59132841, 59153079, 59169847, 59185134, 59216471, 59224383; b) REF '89-10045, GTIN 50749756980123 (cs), 00749756980128 (unit), Lot Numbers: 58714313; c) REF '89-10115, GTIN 50749756977901 (cs), 00749756980128 (unit), Lot Numbers: 58746278; d) REF '89-10213, GTIN 50749756350131 (cs), 00749756350136 (unit), Lot Numbers: 58745371; e) REF '89-10505, GTIN 50749756363124 (cs), 00749756363129 (unit), Lot Numbers: 58774885, 58774885; f) REF '89-10563, GTIN 50749756363988 (cs), 00749756363983 (unit), Lot Numbers: 58800174; g) REF '89-1495, GTIN 50749756214730 (cs), 00749756214735 (unit), Lot Numbers: 58762104; h) REF '89-4479, GTIN 50749756591527 (cs), 00749756591522 (unit), Lot Numbers: 58810330; i) REF '89-5424, GTIN 50749756636730 (cs), 00749756636735 (unit) Lot Numbers: 58698974; j) REF '89-6606, GTIN 50749756686421 (cs), 00749756686426 (unit) Lot Numbers: 58698907; k) REF '89-7369, GTIN 50749756736690 (cs), 00749756736695 (unit) Lot Numbers: 58777761; l) REF '89-7378, GTIN 50749756736409 (cs), 00749756736404 (unit) Lot Numbers: 58811834; m) REF '89-7540, GTIN 50749756741410 (cs)…

Reason for recall

The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

FDA-determined cause: Process control

Action taken

DeRoyal disseminated an URGENT! DEROYAL RECALL NOTICE to its consignees on 05/30/2023 by email. The notice explained the issue, the risk, and requested the return of the affected products. Distributors were also directed to identify and notify their customers.

Details

Recall number
Z-2086-2023
Initiated
May 30, 2023
Posted by FDA
July 3, 2023
Product code
LRO – General Surgery Tray
Quantity
4225 packs
Distribution
US Nationwide distribution.
Recalling firm
DeRoyal Industries Inc, Powell, TN

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2087-2023 Class IICustom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. 05/30/2023Open, Classified
Z-2088-2023 Class IICustom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF…The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. 05/30/2023Open, Classified
Z-2089-2023 Class IICustom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. 05/30/2023Open, Classified
Z-2090-2023 Class IICustom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102…The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. 05/30/2023Open, Classified