Cardinal Health Surgical Gowns X-Large Recalled for Packaging Seal Defect
Cardinal Health is recalling 146,939 units of Poly-Reinforced Surgical Gowns (X-large, SKU 9040) due to potential compromised packaging seals that could affect sterility. Affected products 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: This is an FDA Class II recall of a risk-of-harm medical device (sterile surgical gowns). Although no illnesses or injuries have been reported, compromised sterility poses a potential risk of infection during surgical procedures.
Plain-English summary
Cardinal Health is recalling 146,939 units of Poly-Reinforced Surgical Gowns in X-large size (SKU 9040) due to a potential defect in the packaging seals. The affected gowns may have compromised seals that could compromise the sterility of the product.
Affected gowns were distributed worldwide, including throughout the United States and to Chile, Thailand, Canada, Israel, and various Latin American countries. The recall applies to multiple lot numbers: 20MEQ001, 21AEQ00, 21BEQ001, 21BEQ002, 21BEQ003, 21CEQ001, 21DEQ001, 21DEQ002, 21EEQ001, 21EEQ002, 21FEQ001, 21FEQ002, 21GEQ001, 21HEQ001, 21HEQ002, 21JEQ001, and 21JEQ002. The Universal Device Identifier (UDI) for the case is 50192253018989 and for individual units is 10192253018981.
Compromised sterility of surgical gowns could potentially allow bacteria or other contaminants to reach the wearer during surgical procedures. Healthcare facilities and distributors in possession of affected gowns should cease use and contact Cardinal Health regarding returns or replacement. No illnesses or injuries have been reported at this time.
The recalled product
- Product
- Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
- Manufacturer
- Cardinal Health
- Category
- Medical Device — Surgical Gowns
- Affected units
- 146,939
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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