Recall Z-0799-2015
Teleflex Medical · initiated November 12, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal intubation and are indicated for airway management.
Codes / lots: Product Code: 5-10116, Lot number: 01A1400211
Reason for recall
Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube.
FDA-determined cause: Process control
Action taken
Consignees were notified by an Urgent Medical Device Recall Notification letter on 11/12/2014. The letter identified the affected product, as well as, the reason for the recall. Customers are instructed to immediately discontinue use of and quarantine any affected product. They are also instructed to complete and fax or e-mail the enclosed Recall Acknowledgement Form regardless of whether they have affected product in stock or not. Upon receipt of the form, a customer service representative will contact customers to provide an RGA number, as well as, instructions for the return of the product. A local sales representative or customer service should be contacted with questions at 1-866-246-6990.
Details
- Recall number
- Z-0799-2015
- Initiated
- November 12, 2014
- Posted by FDA
- December 12, 2014
- Terminated
- October 13, 2017
- Product code
- BTR – Tube, Tracheal (W/Wo Connector)
- Quantity
- 14,000 units
- Distribution
- Worldwide Distribution -- U.S., Belgium, Canada, and Japan.
- Recalling firm
- Teleflex Medical, Durham, NC