Recall Z-3213-2011 ยท CCW Laryngoscope, Rigid
Penlon, Ltd. (Fmly East Healthcare)
Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no 50647 Disposable laryngoscope blades
| Date | Sep 14, 2011 (initiated Mar 10, 2011) |
| Status | Terminated |
| Reason | Disposable laryngoscope blades incorrectly labeled with wrong size. |
| Root cause | Other |
| Action | Penlon Ltd ( frmly East Healthcare ) sent an " Urgent Field Safety Notice" dated March 7, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to check their stock with expiry dates between August 2010 to July 2015, and ensure that the sizes written on the blades, inner plastic bags, and the carton all match. Please complete the reply form below and send to the address provided. If you have any stock where the sizes on the bags, blades, and carton do not match, quarantine the blades and c |
| Quantity | 5 cartons (20 blades each) |
| Distribution | Worldwide Distribution -- USA (nationwide) including the states of CA, VA and WI., and the countries of Belgium, Ireland, France, Netherlands, Norway, Portugal, Switzerland, UK, Hong Kong, Greece, Bahrain and China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.