Z-0505-2013Class II

WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral Regions...

Name: Z-0505-2013 WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral Regions...
Creator: ConMed Corporation
Published: 2012-11-20
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2012-11-20 / Terminated / root cause: design

FDA source

ConMed Corporation began a recall of WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral Regions, 21 g x 15 mm long needle. --- Common Name... on 2012-11-20. FDA classified it as Class II and gives the reason as "ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device will not fit...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0505-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-20
Posted: 2012-12-10
Terminated: 2015-08-25
Recalling firm: ConMed Corporation
Product: WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices.
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device will not fit through the instrument channel of a 2.0 mm bronchoscope, it must be replaced with an alternate device and could result in minor inconvenience to the user.
Root cause tag: design
FDA root cause: Component design/selection
Action: ConMed Corporation sent an Urgent Field Safety Notice letter dated November 30, 2012 with Response Form , to all affected customers via USPS Priority Mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete Attachment II and return it with any unused affected product to: ConMed Corporation 525 French Road, Utica, NY 13502 United Sates of America For information regarding this recall call 315-624-3225.
Quantity in commerce: Total 452
Distribution: Worldwide Distribution - USA including CA , FL, IA, IN, MA, MD, ME, MO, MS, NC, NM, OH, PA, TX. Foreign distribution to Spain, Portugal, Japan and Hungary.
Product codes and lots: Beginning Lot Code 1209171, Ending Lot Code 1209201. Lot codes on boxes and packaging contain a lot code in the following form 12 09 17 1 where 12 represents the year (2012), 09 represents the month (September), 17 is the day of the month, and 1 is the Manufacturing Shift Code (1, 2, 3, 4, 5, 6 or 9).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0505-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0502-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-10
Z-0503-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-10
Z-0504-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-10
Z-0505-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-10

Product code EOQ

K914181Class IIWang/mill-Rose Transbronchial Aspiration NeedleMill-Rose Laboratory / cleared 1991-12-10

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)