Z-1221-2012

Crystal Metal Disposable Blades size Mac 4 (part number 50674, 50674/F, 50674/BMI) and Mac 3 (part numbers...

Name: Z-1221-2012 Crystal Metal Disposable Blades size Mac 4 (part number 50674, 50674/F, 50674/BMI) and Mac 3 (part numbers...
Creator: Penlon, Ltd.
Published: 2011-09-21
License: https://open.fda.gov/license/

Penlon, Ltd. / initiated 2011-09-21 / Terminated / root cause: labeling and UDI

FDA source

Penlon, Ltd. began a recall of 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... on 2011-09-21. 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-1221-2012
Status: Terminated
Initiated: 2011-09-21
Posted: 2012-03-18
Terminated: 2012-06-19
Recalling firm: Penlon, Ltd.
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.
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: 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.
Product codes and lots: All lots with expiration dates between August 2011 and August 2016.

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)