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Recall Observatory FDA recall evidence

Device product

Tracheopart Set (Right), Sterile

Z-2413-2015

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-2413-2015

Official wording

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

Code information: Product Code 116401-000750  Batch Number 13FT06, 13GT24, 13JT21, 13IT21R, 13KT23, 13KT23R, 14CT21, 14ET11, 14ET22, 14ET28, 14FT16, 14GT15, 14GT23, 14IT17, 14JT18; Product Code 116401-000850  Batch Number 13IT05, 13IT21R, 13KT05, 13LT08, 14CT16, 14DT19, 14ET10, 14ET22, 14FT16, 14GT05, 14GT18, 14HT03, 14HT09; Product Code 116401-000950  Batch Number 13JT21R, 14CT06, 14CT16, 14DT20, 14ET23, 14FT04, 14GT05, 14GT18, 14HT17, 14IT08

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.