The Recall Desk
ModerateFDA (Devices)·Z-1247-2017·Announced 2017-03-01

DeRoyal Heart Tracecart Recall Due to Contained Chest Drainage Product Issue

DeRoyal Industries is recalling Heart Tracecarts because they contain a Maquet Getinge chest drainage product affected by a separate packaging recall.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is a packaging configuration issue with a contained product, and no illnesses or injuries are reported in the source text.

Plain-English summary

DeRoyal Industries Inc is recalling 849 units of DeRoyal Heart Tracecart REF 53-1769. These are prescription-only, non-sterile products that contain a sterile Maquet Getinge Group chest drainage product.

The recall is necessary because the contained Maquet Getinge chest drainage product was previously recalled due to issues with the current packaging configuration of the Atrium Ocean, Oasis, Express, and Express Mini chest drainage products. The DeRoyal Tracecart is being recalled to ensure the affected chest drainage components are removed from use.

The affected units were distributed in Mississippi and Louisiana. Consumers and healthcare facilities should check their inventory for the specific lot numbers listed in the official recall notice and stop using these products immediately. They should contact DeRoyal Industries for instructions on how to return or dispose of the recalled items.

The recalled product

Product
DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Chest Drainage
Hazard
Affected units
849

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot Numbers: 27453624
  • 28013145
  • 28103757
  • 28117631
  • 28158774
  • 28215628
  • 28230174
  • 28252349
  • 28299104
  • 28317940
  • 28326230
  • 28405309
  • 28455138
  • 28486735
  • 28506265
  • 28568132
  • 28609969
  • 28631875
  • 28736343
  • 28793541

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · DeRoyal Industries Inc

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Same hazard · packaging defect

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