FDA Device

Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no 50647 Disposable laryngoscope blades

Hazard

Disposable laryngoscope blades incorrectly labeled with wrong size.

What You Should Do

Remedy

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.

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Products

Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no 50647 Disposable laryngoscope blades
Brand
Penlon, Ltd. (Fmly East Healthcare) Abingdon Science Park Barton Lane Abingdon United Kingdom
UPC
All lots with expiration dates between August 2010 and July 2015

Units Affected

5 cartons (20 blades each)

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