Recall Z-0705-2018 ยท CCW Laryngoscope, Rigid
Teleflex Medical
Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.
| Date | Feb 23, 2018 (initiated Jan 10, 2017) |
| Status | Terminated |
| Reason | The pouch may contain the incorrect Rusch Green Lite product size. Pouches that are labeled as containing RUSCH GREEN LITE MAC 1 may instead contain RUSCH GREEN LITE MAC 2. |
| Root cause | Package design/selection |
| Action | The firm initiated their recall by letter on 01/10/2018 via FedEx 2-day. Affected consignees were instructed to take the following actions: "1. If you have affected stock, immediately discontinue use and quarantine any products with the product code and lot number listed above, so that the affected products can be returned to Teleflex. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service |
| Quantity | 2140 units |
| Distribution | US only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.