FDA Medical Device Recalls (openFDA)
Teleflex Medical: Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.
- Recall number
- Z-0246-2016
- Recalling firm
- Teleflex Medical
- Product
- Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.
- Status
- Terminated
- Initiated
- 2015-08-24
- Posted
- 2015-11-06
- Terminated
- 2017-09-25
- Reason
- Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.
- Root cause
- Unknown/Undetermined by firm
- Action
- Consignees were notified by letter on 08/24/2015. They were instructed to immediately discontinue use and quarantine any products with the listed catalog numbers. They were to return the product, complete the enclosed Recall Acknowledgement Form and fax or e-mail to recalls@teleflex.com, even if they do not have any of the affected stock. Distributors were instructed to communicate the recall to any of their customers who have received the affected product and to have the customers return any affected product to them with the completed Recall Acknowledgement Form.
- Quantity
- 233,641 units
- Distribution
- Worldwide Distribution -- U.S. Nationwide; International Distribution: Argentina, Austria, Belgium, Belgrade, Cameroon, Canada, Chile, Costa Rica, Croatia, Czech Republic, Ecuador, Denmark, Estonia, Finland, France, French Polynesia, Great Britain, Greece, Guyana, Hong Kong, Ireland, Italy, Jordan, Kuwait, Latvia, Lebanon, Martinique, Netherlands, Panama, Peru, Poland, Portugal, Reunion, Romania, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Venezuela, and the United Arab Emirates.
- Lot, serial or model codes
- Material #503700-000060, Batch numbers: 13IG21, 13LG06, 14AG04, 14FG06, 14GG01, 14LG06, 15AG28, 15CG24 and 15DG38.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BSR
- Firm FEI
- 3005747797
- Firm city
- Research Triangle Park
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28