Z-0277-2016Class II

Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity

Name: Z-0277-2016 Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity
Creator: Teleflex Medical
Published: 2015-10-14
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2015-10-14 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity on 2015-10-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0277-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-14
Posted: 2015-11-16
Terminated: 2017-12-11
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.
Product code: GBW Catheter, Peritoneal
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot Numbers - 73A1500175, 73A1500306, 73B1500116, 73B1500418

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0277-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0277-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-16

Product code GBW

K992907Class IIntraducerTaut, Inc. / cleared 1999-10-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)