Z-3213-2011

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

Name: Z-3213-2011 Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no 50647 Disposable laryngoscope...
Creator: Penlon, Ltd. (Fmly East Healthcare)
Published: 2011-03-10
License: https://open.fda.gov/license/

Penlon, Ltd. / initiated 2011-03-10 / Terminated / root cause: labeling and UDI

FDA source

Penlon, Ltd. (Fmly East Healthcare) began a recall of Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no 50647 Disposable laryngoscope blades on 2011-03-10. The reason FDA records is "Disposable laryngoscope blades incorrectly labeled with wrong size". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3213-2011
Status: Terminated
Initiated: 2011-03-10
Posted: 2011-09-14
Terminated: 2012-09-21
Recalling firm: Penlon, Ltd.
Product: Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no 50647 Disposable laryngoscope blades
Product code: CCW Laryngoscope, Rigid
Reason for recall: Disposable laryngoscope blades incorrectly labeled with wrong size.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: All lots with expiration dates between August 2010 and July 2015

Product code CCW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)