FDA Medical Device Recalls (openFDA)
Penlon, Ltd. (Fmly East Healthcare): Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no 50647 Disposable laryngoscope blades
- Recall number
- Z-3213-2011
- Recalling firm
- Penlon, Ltd. (Fmly East Healthcare)
- Product
- Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no 50647 Disposable laryngoscope blades
- Status
- Terminated
- Initiated
- 2011-03-10
- Posted
- 2011-09-14
- Terminated
- 2012-09-21
- Reason
- Disposable laryngoscope blades incorrectly labeled with wrong size.
- 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
- 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.
- Lot, serial or model codes
- All lots with expiration dates between August 2010 and July 2015
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CCW
- Firm FEI
- 3002807907
- Firm city
- Abingdon
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28