The Recall Desk
HighFDA (Devices)·Z-0609-2023·Announced 2022-12-21

DeRoyal HEART PACK procedure kits recalled for defective component

DeRoyal Industries is recalling 102 HEART PACK procedure kits (Lot 57367401, expiration 3/1/2025) distributed across 23 U.S. states because they contain recalled 3M Health Care Steri Drapes.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall without reported illnesses or injuries; involves a recalled component representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

DeRoyal Industries Inc is recalling HEART PACK procedure kits (Reference 89-8351.12, Lot 57367401, expiration date March 1, 2025). The recall involves 102 kits.

These procedure packs are being recalled because they contain 3M Health Care Steri Drapes that have been recalled by the FDA. The specific defect or hazard associated with the Steri Drapes component is not specified in the available notice.

The recalled kits were distributed to healthcare facilities across 23 U.S. states including Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.

The recalled product

Product
DeRoyal HEART PACK, REF 89-8351.12
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical / Procedure Packs
Hazard
  • component-defect

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 (1)

  • Lot Numbers: Lot 57367401 exp 3/1/2025

Distribution

Distribution scope not specified by the agency.

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