Recall Z-1221-2012 ยท CCW Laryngoscope, Rigid
Penlon, Ltd.
Crystal Metal Disposable Blades size Mac 4 (part number 50674, 50674/F, 50674/BMI) and Mac 3 (part numbers 50675, 50675/F, 50675/BMI) Product Usage: Disposable laryngoscope blades.
| Date | Mar 18, 2012 (initiated Sep 21, 2011) |
| Status | Terminated |
| Reason | Disposable laryngoscope blades incorrectly labeled with wrong size. |
| Root cause | Error in labeling |
| Action | InterMed Penlon sent and Urgent Field Safety Notice letter dated September 21, 2011 to affected customers. The letter identified the affected product, problem and advice on actions to be taken by user. Customers were instructed to complete the Reply Form and send to the address provided. |
| Quantity | 24,940 cartons |
| Distribution | Worldwide Distribution - USA (nationwide) in the countries of Belgium, France, Greece, Ireland, Italy, Lithuania, Netherlands, Norway, Portugal, Switzerland, Canada, China, Hong Kong and Malaysia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.