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U.S. Department of Health and Human Services

Class 2 Device Recall Crystal Metal Miller Disposable Blades

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  Class 2 Device Recall Crystal Metal Miller Disposable Blades see related information
Date Initiated by Firm March 10, 2011
Date Posted September 14, 2011
Recall Status1 Terminated 3 on September 21, 2012
Recall Number Z-3213-2011
Recall Event ID 58820
Product Classification Laryngoscope, rigid - Product Code CCW
Product Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no 50647

Disposable laryngoscope blades
Code Information All lots with expiration dates between August 2010 and July 2015
Recalling Firm/
Manufacturer		 Penlon, Ltd. (Fmly East Healthcare)
Abingdon Science Park
Barton Lane
Abingdon United Kingdom
Manufacturer Reason
for Recall		 Disposable laryngoscope blades incorrectly labeled with wrong size.
FDA Determined
Cause 2		 Other
Action Penlon Ltd ( frmly East Healthcare ) sent an " Urgent Field Safety Notice" dated March 7, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to check their stock with expiry dates between August 2010 to July 2015, and ensure that the sizes written on the blades, inner plastic bags, and the carton all match. Please complete the reply form below and send to the address provided. If you have any stock where the sizes on the bags, blades, and carton do not match, quarantine the blades and contact Penlon using the information below. For further questions please call 44 1235 547093.
Quantity in Commerce 5 cartons (20 blades each)
Distribution Worldwide Distribution -- USA (nationwide) including the states of CA, VA and WI., and the countries of Belgium, Ireland, France, Netherlands, Norway, Portugal, Switzerland, UK, Hong Kong, Greece, Bahrain and China.
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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