Z-2411-2015Class II
Carlens Bronchial Double Lumen Tube Set (Left) Sterile
Teleflex Medical / initiated 2014-11-21 / Terminated
Teleflex, Inc. began a recall of Carlens Bronchial Double Lumen Tube Set (Left) 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-2411-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Teleflex Medical
- Product
- Carlens Bronchial Double Lumen Tube Set (Left) 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 116101370 Batch Number 13KT12, 13LT04; Product Code 116101390 Batch Number 13KT18; Product Code 116101410 Batch Number 13FT12R, 13GT05, 13JT11, 13JT15; Product Code 116101-000350 Batch Numbers 14JT14; Product Code 116101-000370 Batch Numbers 13FT06, 13FT12, 13FT18, 13GT05, 13GT29, 13HT07, 13HT12, 13HT17, 13IT16, 13IT20R, 13JT08, 13JT21, 13KT12, 13KT18, 13LT04, 13LT14, 14AT08, 14BT14, 14BT15, 14CT11, 14CT16, 14DT10, 14DT15, 14DT19, 14DT24, 14ET10, 14ET11, 14ET22, 14FT04, 14FT05, 14FT10, 14FT13, 14GT10, 14GT11, 14GT15, 14GT21, 14HT17, 14IT05, 14IT11, 14JT09, 14JT14; Product Code 116101-000390 Batch Numbers 13FT06, 13FT12, 13GT05, 13GT23, 13GT29, 13HE35, 13HT17, 13IT05, 13IT16, 13IT20, 13IT20R, 13JT08, 13JT21, 13KT12, 13KT15, 13KT18, 13LT04, 13LT11, 14BT14, 14BT21, 14CT11, 14CT21, 14DT03, 14DT13, 14DT15, 14DT19, 14DT20, 14DT25, 14ET04, 14ET28, 14FT04, 14FT16, 14GT10, 14GT11, 14GT21, 14GT23R, 14HT17, 14HT23, 14HT24, 14IT08, 14JT09, 14JT12; Product Code 116101-000410 - Batch Number 13FT06, 13FT12, 13GT05, 13GT24, 13GT29, 13HT07, 13HT12, 13HT17, 13IT16, 13IT20R, 13JT08, 13JT11, 13JT15, 13JT21, 13KT12, 13KT15, 13KT23, 13LT08, 13LT14, 13LT18, 14AT20, 14BT21, 14CT11, 14CT16, 14CT20, 14DT13, 14DT19, 14ET05, 14ET10, 14ET28, 14FT13, 14FT16, 14GT15, 14GT18, 14GT21R, 14HT03, 14HT17, 14HT23, 14HT24, 14JT09
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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