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White Bronchial Double Lumen Tube Set (Right) Sterile

FDA Recall #Z-2414-2015 — Class II — November 21, 2014

Recall #Z-2414-2015 Date: November 21, 2014 Classification: Class II Status: Terminated

Product Description

White 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 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

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.

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