FDA Medical Device Recalls (openFDA)
Teleflex Medical: Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
- Recall number
- Z-0277-2016
- Recalling firm
- Teleflex Medical
- Product
- Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
- Status
- Terminated
- Initiated
- 2015-10-14
- Posted
- not on file
- Terminated
- 2017-12-11
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- Recall letters were sent to customers and distributors. The letter requested that the accounts discontinue use and quarantine for return any product. The distributors were requested to conduct a sub-recall. The letters included a Recall Acknowledgement Form which was to be returned to Teleflex.
- Quantity
- 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.
- Lot, serial or model codes
- Lot Numbers - 73A1500175, 73A1500306, 73B1500116, 73B1500418
- 510(k) numbers
- ["K992907"]
- PMA numbers
- not on file
- Product code
- GBW
- Firm FEI
- 3005747797
- Firm city
- Research Triangle Park
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28