Recall Z-2729-2020 ยท CCW Laryngoscope, Rigid
TELEFLEX MEDICAL INC
Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
| Date | Jul 6, 2020 |
| Status | Terminated |
| Reason | Breaking at the point of a welded joint |
| Root cause | Process control |
| Action | Teleflex issued an Urgent Medical Device Recall on 07/06/2020. It states the following: 1. Immediately discontinue distribution and quarantine any products with the product code and lot number listed. 2. Using the provided customer letter and recall acknowledgement form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. In the event that an alternative app |
| Quantity | 20600 units |
| Distribution | US Nationwide distribution including in the states of FL, KY, CA, ND, UT, MA, MD, AZ, MS, TX, MI, WV, AL, MO, SC, VA, AR, PA, OK, NV, NM, NE, IN, IA, NY, GA, NJ, MN, IL, NC, NH, TN, ID, CO, HI, MT, OR, ME, CT, LA, OH, RI, SD, WA, DC, KS, AK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.