Skip to content
Recall Observatory FDA recall evidence

Device product

White Bronchial Double Lumen Tube Set (Right) Sterile

Z-2414-2015

November 21, 2014

Class II

Product summary

Firm
Teleflex, Inc.
Event
Event 71727
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2414-2015

Official wording

Reason: Customer complaints reporting that the cobb connector detached from the main connector prior to use.

Code information: Product Code 116201-000350 Batch Number 13FT17, 13GT05, 13GT24, 13HT07, 13HT12, 13HT17, 13IT16, 13IT20, 13JT20, 13JT21, 13JT25R, 13KT05, 13KT05R, 13KT12, 13KT23, 13LT08, 14CT06, 14CT11, 14CT20, 14DT03, 14DT06, 14DT19, 14ET10, 14ET23, 14ET28, 14FT04, 14FT05, 14FT13, 14FT16, 14GT18, 14GT21, 14HT03, 14HT17, 14HT24, 14IT08, 14JT14, 14JT21; Product Code 116201-000370 Batch Number 13FT06, 13GT11, 13GT29, 13HT12, 13HT17, 13IT10, 13IT16, 13IT20R, 13JT08, 13JT20, 13JT25, 13KT05, 13KT12, 13KT23, 13LT08, 13LT11, 14AT08, 14CT06, 14CT11, 14CT20, 14DT19, 14DT24, 14ET04, 14ET10, 14ET22, 14ET23, 14FT04, 14FT13, 14GT18, 14GT21, 14HT03, 14HT20, 14HT23, 14IT05, 14IT08, 14JT14, 14JT18; Product Code 116201-000390 Batch Number 13FT06, 13GT11, 13HT07, 13HT12, 13IT10, 13IT16, 13IT20, 13IT20R, 13JT08, 13JT08R, 13JT20, 13JT21, 13KT12, 13KT18, 14BT16, 14CT06, 14CT16, 14CT20, 14DT03, 14DT13, 14DT24, 14ET10, 14ET23, 14ET28, 14FT13, 14FT16, 14GT05, 14GT18, 14GT21, 14HT03, 14HT09, 14HT20, 14HT23, 14IT08, 14IT14; Product Code 116201-000410 Batch Number 13IT20, 13JT25R, 13KT05R, 13KT12, 13KT15, 13KT18, 13LT11, 14AT08, 14CT11, 14CT16, 14CT21, 14DT13, 14DT19, 14ET04, 14ET22, 14ET28, 14GT18, 14HT03, 14HT17, 14JT12

Distribution pattern: AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV. WI, DC, Puerto Rico, Canada, Bolivia, Ecuador, Hong Kong, Malaysia, Philippines, Taiwan, Trinidad & Tobago

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Customer complaints reporting that the cobb connector detached from the main connector prior to use.