Bard Access Systems Recalls HemoStar XK Hemodialysis Catheters for Incorrect Expiration Date
Bard Access Systems is recalling 120 units of 16 Fr HemoStar XK Long-Term Hemodialysis Catheters because they were labeled with an incorrect expiration date.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a documentation/labeling error (incorrect expiration date) rather than a physical defect or contamination.
Plain-English summary
Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long-Term Hemodialysis Catheters. The recalled devices are part of a Standard kit containing an AirGuard introducer and are used for patients requiring hemodialysis. The catheters are made of radio-opaque polyurethane and allow for flow rates as high as 500 ml/min during treatment.
The recall was initiated because the devices were identified with an incorrect expiration date. The label indicated an expiration date of 03/2015, whereas the correct expiration date is 10/2013. The recall involves 120 units of Product Code 5883730, lot number REVK0125.
The affected units were distributed nationally in the United States to the following states: MO, KS, AZ, OK, OR, AL, MA, TX, FL, MI, OH, LA, NJ, NC, WA, and AR. The source text does not specify instructions for consumers or healthcare providers regarding the disposition of these devices.
The recalled product
- Product
- 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. The HemoStar XK catheter is made of radio-opaque polyurethane and allows for flow rates as high as 500 ml/min…
- Manufacturer
- Bard Access Systems
- Hazard
- Affected units
- 120
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product Code 5883730 lot number REVK0125.
Distribution
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