—#132777

Product

AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

FDA product code: BTT — Humidifier, Respiratory Gas, (Direct Patient Interface)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K833974
Affected lot / code info: Product Code: 003-40F, Lot numbers: 506147, 238137, 288137, 298137, 292147, 062147, 045147, 066147, 565137, 393137, 468137, 242137, 404137, 462147, 462137, 511137, 077147, 360137, 384137, 350137, 267137, 233147, 314137, 388137, 542137, 525137, 302137, 014147, 276147, 046147, 198147, 258147, 277147, 490147, 482147, 192147, 057147, 117147, 227147, 011147, 120147, 464137, 201147, 382137, 073147, 002147, 505147, 480147, 195147, 598137, 005147, 601137, 333137, 251147, 291137, 521137, 535137, 489147, 301137, 347137, 386137, 562137, 466137, 091147, 459147, 589137, 595137, 068147, 508137, 325137, 285137, 254147, 395137, 327137, 357137, 310137, 539137, 496137, 049147, 053147, 093147, 009147, 007147, 587137, 591137, 344137, 399137, 584137, 121147, 188147, 494147, 330137, 402137, 339137, 519137, 264137 & 260137.

Why it was recalled

The packages may contain foreign material (black particles).

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

Teleflex sent and Urgent Medical Device Recall Notification letter dated January 14, 2015 to all affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products with the affected catalog numbers and lot numbers. Customers were asked to complete and return the enclosed Recall Acknowledgement Form. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-01-14
Posted by FDA: 2015-02-12
Terminated: 2017-12-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132777. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.