Custom medical procedure packs labeled as: a) OPEN recall: Sterility Concern
Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF…
Why was Custom medical procedure packs labeled as: a) OPEN recalled?
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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 Numbers: 58823595; q) REF '89-8445, GTIN 50749756840090 (cs), 00749756840095 (unit), , Lot Numbers: 58697963; r) REF '89-8482, GTIN 50749756848331 (cs), 00749756848336 (unit), Lot Numbers: 58789411; s) REF '89-9131, GTIN 50749756945030 (cs), 00749756945035 (unit), , Lot Numbers: 58808416; t) REF '89-9287, GTIN 50749756938001 (cs), 00749756938006 (unit), , Lot Numbers 58789260; u) REF '89-9626, GTIN 50749756927661 (cs), 00749756927666 (unit), , Lot Numbers: 58738315 v) REF '89-9632, GTIN 50749756927593 (cs), 00749756927598 (unit), , Lot Numbers: 58701598
- 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…
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 4225 packs
- Distribution
- US Nationwide distribution.
- Recall date
- July 12, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)