Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no 50647 Disposable laryngoscope blades
FDA Recall Z-3213-2011 · Posted 2011-09-14
Recalling FirmPenlon, Ltd. (Fmly East Healthcare)
Recall StatusTerminated
Product CodeCCW
Date Initiated2011-03-10
Date Terminated2012-09-21
Product Quantity5 cartons (20 blades each)
Reason for Recall
Disposable laryngoscope blades incorrectly labeled with wrong size.
Firm 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 contact Penlon using the information below.
For further questions please call 44 1235 547093.
Root Cause
Other
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.