HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
This recall has been terminated (originally issued August 20, 2015).
- Company
- Teleflex Medical
- Recall Initiated
- June 1, 2015
- Posted
- August 20, 2015
- Terminated
- April 16, 2018
- Recall Number
- Z-2370-2015
- Quantity
- 188,195 total units
- Firm Location
- Research Triangle Park, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The double swivel connector may crack or separate on the endobronchial tube.
Distribution
Worldwide Distribution - US (nationwide) and the countries of: The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam.
Lot / Code Info
Product Code: 5-15401, Lot numbers: 01K1300254, 01L1300393, 01M1300212, 01A1400436, 01C1400086, 73D1400096, 73D1400496, 73E1400269, 73F1400153, 73F1400352, 73G1400052, 73G1400288, 73H1400331, 73J1400401, 73L1400106, 73M1400208, 73A1500345, 73B1500272 and 73C1500255.
Root 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.