Reported Mar 1, 2017 · Terminated
DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
DeRoyal Industries Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703
Is this the product you have?
- DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
- Lot codes and dates
- Lot Numbers
185 of 185 codes
27453624280131452810375728117631281587742821562828230174282523492829910428317940283262302840530928455138284867352850626528568132286099692863187528736343287935412885418028908555 289617272901583929083612291695122921427229271744293392942941277129522363297223572975403329799485298507543002152330092305300926043013425330179216307284653081973830957330310106913101544131103782312961663140299331469522314697093157622131601554316719073233386232335500323557463255084132618796326895273272868832764718
- Lot Numbers
- Amount recalled
- 849 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which was subsequently recalled due to the current packaging configuration of the Atrium Ocean, Oasis, Express and Express Mini chest drainage products.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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