Cardinal Health Surgical Gowns Recalled Due to Compromised Packaging Seals
Cardinal Health Poly-Reinforced Surgical Gowns (XX-large, SKU 9070) are recalled due to potential open packaging seals that could compromise sterility. Approximately 29,893 units distributed worldwide may be affected.
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 medical device recall involving surgical gowns where packaging seal compromise could result in loss of sterility. While no illnesses or injuries have been reported, this represents a risk-of-harm product where sterility failure during medical procedures poses potential for serious patient harm.
Plain-English summary
Cardinal Health is recalling Poly-Reinforced Surgical Gowns XX-large (SKU 9070) due to a potential packaging defect affecting approximately 29,893 units. The affected product lot numbers are 21CKQ001, 21CKQ002, and 21HKQ001.
The surgical gowns have the potential for open packaging seals, which compromises the sterility of the product. Sterile surgical gowns are critical barrier protection for preventing infection during medical procedures.
The affected gowns were distributed worldwide, including throughout the United States and internationally to Chile, Thailand, Canada, Israel, and various Latin American locations including Qatar, Panama, Mexico, Colombia, and Costa Rica.
Healthcare facilities that received affected lot numbers should immediately cease use of the recalled gowns and contact Cardinal Health for instructions on replacement or proper disposition of the product.
The recalled product
- Product
- Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
- Manufacturer
- Cardinal Health
- Affected units
- 29,893
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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