Recall Z-2368-2015
Teleflex Medical · initiated June 1, 2015
Class I – dangerous or defective products that could cause serious health problems or death
Product
HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation.
Codes / lots: Product Code: 5-16128, Lot numbers: 73L1400012, 73K1400582, 73L1400233 and 73A1500039; Product Code: 5-16135, Lot numbers: 73B1500259, 73B1500293, 73C1500401, 73C1500426, 01K1300470, 01B1400479, 73D1400498, 73F1400096, 73H1400443, 73J1400117, 73K1400583, 73L1400094, 73A1500205, 73A1500206 and 73B1500258; Product Code: 5-16137, Lot numbers: 73B1500354, 73B1500355, 73C1500402 and 73C1500427; Product Code: 5-16139, Lot numbers: 73G1400177, 73H1400444, 73L1400095, 73A1500041 and 73A1500203; Product Code: 5-16141, Lot numbers: 01L1300156, 01A1400452, 73G1400178, 73G1400510, 73H1400009, 73K1400553 and 73B1500257.
Reason for recall
The double swivel connector may crack or separate on the endobronchial tube.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated June 1, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were directed to contact any customers who had received the product included within the scope of this recall. Customers were directed to immediately discontinue use and quarantine any products with the referenced catalog numbers and lot numbers listed in the notification. Additionally, customers were asked to return any affected product together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
Details
- Recall number
- Z-2368-2015
- Initiated
- June 1, 2015
- Posted by FDA
- August 20, 2015
- Terminated
- April 16, 2018
- Product code
- CBI – Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- Quantity
- 188,195 total units
- Distribution
- Worldwide Distribution - US (nationwide) and the countries of: The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam.
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2367-2015 Class I | HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35…The double swivel connector may crack or separate on the endobronchial tube. | 06/01/2015Terminated |
| Z-2369-2015 Class I | HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile. Used to aspirate…The double swivel connector may crack or separate on the endobronchial tube. | 06/01/2015Terminated |
| Z-2370-2015 Class I | HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile.…The double swivel connector may crack or separate on the endobronchial tube. | 06/01/2015Terminated |