Recall Z-1221-2012
Penlon, Ltd. · initiated September 21, 2011
Product
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.
Codes / lots: All lots with expiration dates between August 2011 and August 2016.
Reason for recall
Disposable laryngoscope blades incorrectly labeled with wrong size.
FDA-determined cause: Error in labeling
Action taken
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.
Details
- Recall number
- Z-1221-2012
- Initiated
- September 21, 2011
- Posted by FDA
- March 18, 2012
- Terminated
- June 19, 2012
- Product code
- CCW – Laryngoscope, Rigid
- 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.
- Recalling firm
- Penlon, Ltd., Abingdon