Teleflex Recalls Taut Operative Cholangiogram Catheters Due to Missing Metal Support Tube
Teleflex Medical is recalling 450 Taut Operative Cholangiogram Catheters because the metal support tube is missing. The recall covers units distributed in the US and Belgium.
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, and the hazard involves a missing structural component in a medical device used during surgery, which presents a risk of harm even though specific injuries are not detailed in the source text.
Plain-English summary
Teleflex Medical is recalling 450 units of the Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm. The recall was initiated after several complaints were received regarding the metal support tube being missing from the catheter. This device is used to facilitate the introduction of contrast media into the biliary ducts to obtain a cholangiogram during laparoscopic or open cholecystectomy.
The affected product is identified by Product Code 18400 and Lot No. 01A1400037. The units were distributed worldwide, including in the United States (specifically AL, AZ, AR, CA, CO, FL, IL, LA, ME, MI, MO, NY, OH, OR, TN, TX, VT, and WI) and Belgium. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and facilities that have received this product should stop using it and contact Teleflex Medical for further instructions on return or disposal. Patients who have had this device used during a procedure should contact their healthcare provider if they have concerns or experience any issues.
The recalled product
- Product
- Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the introduction of contrast media into the biliary ducts to obtain a cholangiogram during laparoscopic or open cholecystectomy.
- Manufacturer
- Teleflex Medical
- Affected units
- 450
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 Code 18400
- Lot No. 01A1400037
Distribution
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