Z-2414-2015Class II
White Bronchial Double Lumen Tube Set (Right) Sterile
Teleflex Medical / initiated 2014-11-21 / Terminated
Teleflex, Inc. began a recall of White Bronchial Double Lumen Tube Set (Right) Sterile on . FDA classified it as Class II and gives the reason as "Customer complaints reporting that the cobb connector detached from the main connector prior to use". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-2414-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Teleflex Medical
- Product
- White Bronchial Double Lumen Tube Set (Right) Sterile
- Product code
- BTS Tube, Bronchial (W/Wo Connector)
- Reason for recall
- Customer complaints reporting that the cobb connector detached from the main connector prior to use.
- FDA root cause
- Other
- Action
- Recall letters were sent on 11/21/2014 to consignees requesting them to discontinue use and quarantine the products. The letter includes a reply form to be returned. The letter to the distributors requested a sub-recall, and included a recall letter to be sent to their accounts.
- 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
- Product codes and lots
- 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
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2407-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2408-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2409-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2410-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2411-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2412-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2413-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2414-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2415-2015 | Class II | Terminated | Voluntary: Firm initiated |
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