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U.S. Department of Health and Human Services

Class 2 Device Recall Crystal Metal Disposable Blades

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  Class 2 Device Recall Crystal Metal Disposable Blades see related information
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
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
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
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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