| Class 2 Device Recall Crystal Metal Disposable Blades | |
Date Initiated by Firm | September 21, 2011 |
Date Posted | March 18, 2012 |
Recall Status1 |
Terminated 3 on June 19, 2012 |
Recall Number | Z-1221-2012 |
Recall Event ID |
59992 |
Product Classification |
Laryngoscope, rigid - Product Code CCW
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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. |
Code Information |
All lots with expiration dates between August 2011 and August 2016. |
Recalling Firm/ Manufacturer |
Penlon, Ltd. Abingdon Science Park Barton Lane Abingdon United Kingdom
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Manufacturer Reason for Recall | Disposable laryngoscope blades incorrectly labeled with wrong size. |
FDA Determined Cause 2 | 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 in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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