Teleflex Medical: Medical Device Recall in 2015 - (Recall #: Z-1100-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 14, 2015

Date Posted: February 18, 2015

Recall Number: Z-1100-2015

Event ID: 70280

Reason for Recall:

The packages may contain foreign material (black particles).

Status: Terminated

Product Quantity: 15,779,607 units

Code Information:

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated