Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
Reported: November 25, 2015 Initiated: October 14, 2015 #Z-0277-2016
Product Description
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
Reason for Recall
The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and insertion of another device.
Details
- Recalling Firm
- Teleflex Medical
- Units Affected
- 2050 ea.
- Distribution
- Nationwide Distribution including 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.
- Location
- Research Triangle Park, NC
Frequently Asked Questions
What product was recalled? ▼
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.. Recalled by Teleflex Medical. Units affected: 2050 ea..
Why was this product recalled? ▼
The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and insertion of another device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2015. Severity: Moderate. Recall number: Z-0277-2016.
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