American Catheter Recalls Cholangiogram Catheters Due to Sterilization Seal Failure
American Catheter Corp is recalling 890 Cholangiogram Catheters because they were not sealed before sterilization. The defect was not detected during acceptance or release activities.
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: The recall is classified as FDA Class II. The hazard involves a sterilization failure (unsealed catheters), which poses a risk of infection or harm, but the source text does not report any specific illnesses or injuries, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
American Catheter Corp is recalling 890 units of the Cholangiogram Catheter 9100 Series. The recall was initiated because the catheters were not sealed before the sterilization process. This defect was not detected during subsequent acceptance activities, product release, or distribution.
The affected devices are identified by Product Number 9100 and Lot # 14101601. These products were distributed in the states of Alabama, Alaska, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kansas, Louisiana, Michigan, Missouri, Montana, New Jersey, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Washington, and Wisconsin.
Consumers and healthcare facilities should stop using these devices and contact American Catheter Corp for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- American Catheter / Cholangiogram Catheter 9100 Series.
- Manufacturer
- American Catheter Corp
- Category
- Medical Device — Catheters
- Affected units
- 890
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 (2)
- Product Number is 9100
- Lot # 14101601.
Distribution
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