Sheridan Preformed Cuffed Tracheal Tube, Nasal 6.5, Catalog Number: 5-22313, Teleflex Medical Ltd, Research Triangle Par
FDA device recall Z-1890-2009 · posted 2009-08-26 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings.
- Action taken
- Consignees were notified by an Urgent Medical Device Recall letter on/about 07/06/2009. They were instructed to discontinue use of and return any of the recalled product to Teleflex Medical. Distributors were advised to forward the letter to their consignees to retrieve relevant product from those locations. A Recall Acknowledgement Form was attached to be returned to Teleflex Medical. Replacement product or credit will be provided to the consignee.
- Root cause
- Process control
- Status
- Terminated
- Product code
- BTR
- Quantity affected
- 1160 total
- Distribution
- Worldwide Distribution -- USA, including states of CA, FL, IL, KY, MA, NC, NM, NJ, OH, PA, RI, TN, TX, UT, VA, WA, and WI and countries of France and Japan.
- Date initiated
- 2009-07-06
- Date posted
- 2009-08-26
- Date terminated
- 2010-08-24
- Location
- Durham, NC
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SHERIDAN/HVT,CF, UNCUFFED (K822082) | Sheridan Catheter Corp. | 1982-08-10 |