Teleflex Medical Recalls Taut Intraducers Due to Gas Leakage Risk
Teleflex Medical is recalling 2,050 Taut Intraducers 10/BX7.5 FR 3.5 devices because a defective component can cause gas leakage, potentially requiring device replacement.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect that necessitates surgical intervention (removal and replacement of the device), meeting the criteria for a Severe rating.
Plain-English summary
Teleflex Medical is recalling 2,050 units of Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. These medical devices are used to provide an access port into the peritoneal cavity. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is being issued because a defective component in the device can cause gas leakage. This leakage can result in the loss of pneumoperitoneum, which may necessitate the removal of the defective device and the insertion of another device.
The affected units were distributed nationwide, including in the states of AK, AZ, AR, CA, CT, FL, GA, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MO, MT, NE, NJ, NY, NC, OH, OK, PA, TN, TX, VA, VT, and WI. The specific lot numbers involved are 73A1500175, 73A1500306, 73B1500116, and 73B1500418. Healthcare providers and facilities should check their inventory for these specific lot numbers and contact Teleflex Medical for further instructions.
The recalled product
- Product
- Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
- Manufacturer
- Teleflex Medical
- Affected units
- 2,050
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 (4)
- Lot Numbers - 73A1500175
- 73A1500306
- 73B1500116
- 73B1500418
Distribution
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