The Recall Desk
HighFDA (Devices)·Z-0378-2022·Announced 2021-12-22

Cardinal Health RoyalSilk Surgical Gowns Recalled for Sterility Compromise

Cardinal Health is recalling 8,950 units of RoyalSilk Non-Reinforced Surgical Gowns due to potential packaging seal defects that could compromise sterility. The affected gowns were distributed worldwide.

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: This is a Class II recall involving a medical device that poses a risk of harm in clinical use (sterility compromise during surgical procedures), but no illnesses or injuries have been reported. This fits the score 3 (High) criterion for risk-of-harm products without documented patient impact.

Plain-English summary

Cardinal Health is recalling 8,950 units of RoyalSilk Non-Reinforced Surgical Gowns (XXX-large, X-long, SKU 95998) due to potential defects in packaging seals. The recalled gowns may have open seals that could compromise their sterility.

The affected lot numbers are 20MMQ007, 21BMQ007, 21CMQ008, 21DMQ001, 21EMQ003, and 21FMQ007, identified by UDI codes 50192253006191 (case) and 10192253006193 (each). The gowns were distributed worldwide, including to the United States, Chile, Thailand, Canada, Israel, Qatar, Panama, Mexico, Colombia, and Costa Rica.

Surgical gowns with open packaging seals may not maintain the sterile barrier necessary for safe use in surgical procedures. Sterility compromise could expose patients to contamination during surgical interventions.

The recalled product

Product
RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
Manufacturer
Cardinal Health
Category
Medical Device — Surgical Apparel
Hazard
  • sterility-compromise
  • packaging-defect

Distribution

Distributed nationwide across the United States.

Related recalls

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