Crystal Metal Disposable Blades size Mac 4 (part number 50674, 50674/F, 50674/BMI) and Mac 3 (part numbers 50675, 50675/
FDA device recall Z-1221-2012 · posted 2012-03-18 · Terminated
Recall details
- Recalling firm
- Penlon, Ltd.
- Reason for recall
- Disposable laryngoscope blades incorrectly labeled with wrong size.
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- CCW
- Quantity affected
- 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.
- Date initiated
- 2011-09-21
- Date posted
- 2012-03-18
- Date terminated
- 2012-06-19
- Location
- Abingdon, United Kingdom
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