Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow trac
FDA device recall Z-0044-2017 · posted 2016-10-18 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- The connector may disconnect from the tracheostomy tube during use.
- Action taken
- Teleflex sent an Urgent Field Safety Notice dated August 26, 2016, to all affected consignees. The letter requested that consignees cease use and distribution of stock, quarantine immediately, and return the product. Also, the letter requested a sub-recall if the product had been further distributed. The letter included an Acknowledgement Form which is to be returned. Customers with questions were instructed to contact their local sales representative or Customer Service. For questions regarding this recall call 610-378-0131.
- Root cause
- Use error
- Status
- Terminated
- Product code
- JOH
- Quantity affected
- 1095 units
- Distribution
- Worldwide Distribution: US (nationwide) to CA and countries of: Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey.
- Date initiated
- 2016-08-26
- Date posted
- 2016-10-18
- Date terminated
- 2017-03-21
- Location
- Morrisville, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE (K964056) | Rusch Intl. | 1997-10-10 |