ConMed Recalls WANG Transbronchial Aspiration Needles Due to Fit Issues
ConMed is recalling WANG Transbronchial Aspiration Needles because they may not fit through a 2.0 mm bronchoscope, causing minor inconvenience.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text explicitly states the issue results in 'minor inconvenience' and requires replacement with an alternate device, with no reported injuries or adverse health consequences, fitting the criteria for a Low severity recall.
Plain-English summary
ConMed Corporation is recalling WANG Transbronchial Aspiration Needles (Cat. No. SW-121) and WANG Cytology Needles. The recall involves 452 units distributed worldwide, including the United States and several foreign countries. These disposable, sterile, single-use devices are designed for use with a bronchoscope to aspirate tissue specimens for staging bronchogenic carcinoma.
The recall was initiated after a user facility reported that the needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device does not fit through the instrument channel, it must be replaced with an alternate device. The source text states that this issue could result in minor inconvenience to the user.
Healthcare facilities should identify affected units by checking the lot codes on the boxes and packaging. The affected lot codes range from 11207241 to 1207251 and from 1209171 to 1210081. The lot code format is YYYYMMDD followed by a manufacturing shift code.
The recalled product
- Product
- WANG Transbronchial Aspiration Needles Cat. No. SW-121, WANG Cytology Needles, Central, Carinal and Mediastinal Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed…
- Manufacturer
- ConMed Corporation
- Hazard
- Affected units
- 452
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Begining Lot 11207241
- Ending Lot Code 1207251
- Beginning Lot Code 1209171
- 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).
Distribution
Part of a larger recall action
This product is one of 4 recalled by ConMed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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