Ballard Closed Suction Catheters recalled for lack of sterility assurance
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 210, 10 F Elbow) for neonates and pediatric patients due to lack of sterility assurance. Approximately 4,000 units were distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a medical device. Per the rubric, FDA Class I recalls must be scored at 4 (Severe) or higher. Although no reported illnesses or injuries are mentioned in the source, the classification itself and the nature of the hazard (lack of sterility assurance for a device in direct patient contact) justify a Severe rating.
Plain-English summary
Avanos Medical, Inc. is recalling Ballard Closed Suction Catheters, Model 210, 10 F Elbow, used in neonatal and pediatric patients. The recall affects approximately 4,000 units distributed nationwide across multiple U.S. states and internationally to South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, and Guadalajara.
The recalled product has been identified as lacking sterility assurance. Lot code 1561165 is affected, with UPC codes 00609038938349 (Each), 10609038938346 (DSP), and 20609038938343 (Case).
Patients, caregivers, and healthcare providers who have received or are using the recalled Ballard Closed Suction Catheters should contact Avanos Medical, Inc. immediately. Healthcare facilities should stop using affected units and return them to the manufacturer. The FDA has classified this as a Class I recall due to the risk associated with non-sterile medical devices intended for direct patient contact.
The recalled product
- Product
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow Component: N/A
- Manufacturer
- Avanos Medical, Inc.
- Hazard
- lack-of-sterility
- contamination-risk
Distribution
Distributed nationwide across the United States.
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