Cardinal Health Surgical Gowns Recalled for Potential Sterility Compromise
Cardinal Health is recalling approximately 17,174 Poly-Reinforced Surgical Gowns (Large, SKU 9010) due to potential compromise of packaging seals that could affect product sterility. Units were distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall of a risk-of-harm medical device (surgical gowns) where packaging seal compromise could result in loss of sterility. No illnesses or injuries have been reported, and the hazard is described as a potential risk rather than confirmed contamination, placing it within the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Cardinal Health is recalling approximately 17,174 units of Poly-Reinforced Surgical Gowns (Large, SKU 9010) due to the potential for open packaging seals to compromise the sterility of the surgical gowns. These gowns are used in surgical and healthcare settings where sterile conditions are critical to patient safety.
The recalled gowns were distributed worldwide, including throughout the United States and to Chile, Thailand, Canada, Israel, Qatar, Panama, Mexico, Colombia, and Costa Rica. Affected lot numbers are: 20MDQ014, 21ADQ007, 21CDQ004, 21CDQ005, 21DDQ001, 21DDQ002, 21EDQ001, 21FDQ001, 21GDQ001, 21HDQ001, and 21JDQ003.
Healthcare providers and facilities that received these gowns should verify the lot numbers against their inventory and discontinue use of affected units. Patients and the general public should not be directly affected, as these are medical-grade products used in professional healthcare settings. Healthcare providers should contact Cardinal Health for guidance on replacement or return of affected products.
The recalled product
- Product
- Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
- Manufacturer
- Cardinal Health
- Affected units
- 17,174
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Cardinal Health 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.
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