Bronchial Double Lumen Tube Set (Right), Sterile
FDA Recall #Z-2408-2015 — Class II — November 21, 2014
Product Description
Bronchial Double Lumen Tube Set (Right), Sterile
Reason for Recall
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Recalling Firm
Teleflex, Inc. — Wayne, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Distribution
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
Code Information
Product Code 162000260 Batch Number 14CT11; Product Code 116200280 Batch Number 13JT05, 13KT18, 14CT11, 14FT05, 14FT10; Product Code 116200350 Batch Number 13FT12R, 13GT11, 13HT07, 13KT23, 14AT08; Product Code 116200370 Batch Number 13KT23, 13LT14, 14DT25, 14ET23; Product Code 116200390 Batch Number 13HT12, 13JT08, 13KT18, 14ET10; Product Code 116200410 Batch Number 14ET05, 14ET22; Product Code 116201350 Batch Number 13FT12R, 13GT05; Product Code 116201410 Batch Number 14ET04; Product Code 116200-000260 Batch Number 13FT12, 13GE29J, 13GT29, 13HT12, 13HT17, 13IT10, 13JT05R, 13JT21, 13LT04, 14DT03, 14ET04, 14ET10, 14ET22, 14FT04, 14GT11, 14GT18, 14GT21, 14HT09, 14HT17; Product Code 116200-000260 - Batch Number 13FT12, 13GE29J, 13GT29, 13HT12, 13HT17, 13IT10, 13JT05R, 13JT21, 13LT04, 14DT03, 14ET04, 14ET10, 14ET22, 14FT04, 14GT11, 14GT18, 14GT21, 14HT09, 14HT17; Product Code 116200-000280 Batch Number 13FT06, 13FT12, 13GE29J, 13HT12, 13HT17, 13IT10, 13JT11, 13KT05, 13KT18, 13LT11, 14CT06, 14CT21, 14DT10, 14DT24, 14ET10, 14ET22, 14FT04, 14FT10, 14GT03, 14GT15, 14GT21, 14HT09, 14IT05, 14IT20; Product Code 116200-000350 Batch Number 13GE28J, 13GT05, 13GT11, 13GT23, 13GT29, 13HT07, 13HT12, 13HT17, 13IT10, 13IT13, 13JT08, 13JT20, 13JT21, 13KT05, 13KT12, 13KT23, 13LT04, 13LT08, 13LT11, 14AT04, 14AT08, 14BT21, 14CT06, 14CT16, 14CT20, 14CT21, 14DT06, 14DT24, 14ET04, 14ET05, 14FT22, 14FT04, 14FT10, 14FT13, 14FT20, 14GT05, 14GT15, 14HT09, 14HT20, 14HT23, 14IT05, 14IT08, 14JT09, 14JT12, 14JT24; Product Code 116200-000370 Batch Number 13FT17, 13GE28J, 13GT05, 13GT16, 13HT12, 13IT05, 13IT10, 13IT16, 13IT20R, 13JT08, 13JT15, 13KT05, 13KT12, 13KT23, 13LT08, 13LT14, 14AT08, 14AT12, 14BT21, 14CT06, 14CT16, 14DT03, 14DT13, 14DT19, 14DT20, 14DT24, 14DT25, 14ET05, 14ET23, 14ET28, 14FT04, 14FT13, 14FT20, 14GT03, 14GT18, 14HT03, 14HT09, 14HT12, 14HT17, 14IT08, 14IT17, 14JT21, 14JT24; Product Code 116200-000390 Batch Number 13FT12, 13FT18, 13GE28J, 13GT16, 13GT29, 13HT12, 13IT05, 13IT10, 13IT13, 13IT20, 13IT20R, 13JT05R, 13JT08, 13JT15, 13JT20R, 13KT05, 13KT18, 13LT08, 14BT15, 14BT16, 14BT21, 14CT11, 14CT16, 14DT13, 14DT15, 14ET04, 14ET10, 14FT04, 14FT16, 14GT03, 14GT15, 14GT21, 14HT03, 14HT17, 14HT23, 14IT05, 14IT08, 14IT17, 14IT20, 14JT12, 14JT24; Product Code 116200-000410 Batch Number 13FT12, 13GE30J, 13GT11, 13GT24, 13GT29, 13HT12, 13HT17, 13IT10, 13IT13, 13IT20R, 13JT05, 13JT05R, 13JT20, 13KT05, 13KT12, 13LT04, 13LT08, 14AT08, 14BT21, 14CT11, 14DT13, 14DT15, 14DT19, 14DT24, 14ET04, 14ET05, 14ET22, 14FT13, 14GT15, 14GT21, 14HT03, 14HT09, 14HT17, 14HT20, 14HT23, 14IT08
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.