Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315 A tracheal
FDA device recall Z-1177-2017 · posted 2017-02-09 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units labeled 7.5mm tube may contain a size 5.5mm tube.
- Action taken
- Teleflex sent an Medical Device Recall Notification letter dated October 18, 2016, to all affected customers. Customers were advised to immediately discontinue use and to quarantine product. The letter to distributors requested a sub-recall. Both letters included an acknowledgement form to be returned. Customers with questions were instructed to contact their local representative or Customer Service at 1-800-246-6990.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTR
- Quantity affected
- 25,274 units
- Distribution
- Worldwide Distribution - US including AL, AZ, ARK, CA, CO, CT, FL, GA. HI, KS, KY, IL, IN, IA, LA, MD, MA, MI, MN, MS, MO, MT, NE, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV and In
- Date initiated
- 2016-10-18
- Date posted
- 2017-02-09
- Date terminated
- 2017-08-25
- Location
- Research Triangle Park, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SHERIDAN/HVT,CF, UNCUFFED (K822082) | Sheridan Catheter Corp. | 1982-08-10 |