Recall Z-2119-2014 ยท CCW Laryngoscope, Rigid
Teleflex Medical
Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.
| Date | Jul 26, 2014 (initiated Jul 9, 2014) |
| Status | Terminated |
| Reason | Packaging Error: Customers have reported receiving incorrect product. The box labeling indicates the correct product MAC 4 but the contents are incorrect, Miller 4 blades. |
| Root cause | Other |
| Action | Teleflex Medical sent an Urgent Medical Device Recall Notification dated July 9, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-866- 804-9881, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. A customer |
| Quantity | 120 units |
| Distribution | US Distribution including the states of FL, GA, KY, MD, MS, MT, PA, SC and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.