Aqua 540 SW recall: Foreign Material
AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a…
Why was Aqua 540 SW recalled?
The packages may contain foreign material (black particles).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code: 005-40, Lot numbers: 005135, 015135, 017135, 029135, 010135, 035135, 006145, 003135, 018135, 034135, 019135, 023135, 028135, 010145, 004145, 008135, 009145, 002145, 030135, 002135, 031135, 016135, 022135, 026135, 021135, 008145, 032135, 007135, 004135, 007145, 009135, 027135, 001145, 005145, 012135, 006135, 020135, 033135, 013135, 001135, 011135, 036135, 025135, 014135 & 003145.
- Product
- AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a…
- Recalling firm
- Teleflex Medical
- Quantity
- 15,779,607 units
- Distribution
- Worldwide Distribution - U.S. Nationwide and the countries of: Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, China, Ecuador, Germany, Great Britain, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Mexico, New Zealand, Philippines, Singapore, South Korea, Saudi Arabia, Taiwan, Thailand, Uruguay and Zambia.
- Recall date
- February 18, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)