Recall Z-0246-2016
Teleflex Medical · initiated August 24, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.
Codes / lots: Material #503700-000060, Batch numbers: 13IG21, 13LG06, 14AG04, 14FG06, 14GG01, 14LG06, 15AG28, 15CG24 and 15DG38.
Reason for recall
Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
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.
Details
- Recall number
- Z-0246-2016
- Initiated
- August 24, 2015
- Posted by FDA
- November 6, 2015
- Terminated
- September 25, 2017
- Product code
- BSR – Stylet, Tracheal Tube
- 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…
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0245-2016 Class II | Rsch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only…Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. | 08/24/2015Terminated |