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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 Recall
Crystal Metal Disposable Blades
see related information
Date Posted March 18, 2012
Recall Status1 Terminated 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
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Disposable laryngoscope blades incorrectly labeled with wrong size.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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