DeRoyal Industries Inc: 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

Hazard

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

Details from the source

Reason for recall: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. Distribution: US Nationwide distribution. Quantity: 4225 packs Lot/code info: 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), 00749756741415 (unit), Lot Numbers: 58737081; n) REF '89-8061, GTIN 50749756807291 (cs), 00749756807296 (unit), Lot Numbers: 58698042; o) REF '89-8187, GTIN 50749756818488 (cs), 00749756818483 (unit), Lot Numbers: 58736862; p) REF '89-8439, GTIN 50749756836925 (cs), 00749756836920 (unit), Lot Nu

UPC codes

50749756864676, 00749756864671, 50749756980123, 00749756980128, 50749756977901, 50749756350131, 00749756350136, 50749756363124, 00749756363129, 50749756363988, 00749756363983, 50749756214730, 00749756214735, 50749756591527, 00749756591522, 50749756636730, 00749756636735, 50749756686421, 00749756686426, 50749756736690, 00749756736695, 50749756736409, 00749756736404, 50749756741410, 00749756741415, 50749756807291, 00749756807296, 50749756818488, 00749756818483, 50749756836925, 00749756836920, 50749756840090, 00749756840095, 50749756848331, 00749756848336, 50749756945030, 00749756945035, 50749756938001, 00749756938006, 50749756927661

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.