Recalls / —

—#128063

Product

Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.

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: 046127, 049127, 052127, 053127, 055127, 056127, 058127, 059127, 061127, 062127, 065127, 066127, 068127, 069127, 071127, 072127, 074127, 211127, 213127, 215127, 217127, 233127, 236127, 238127, 244127, 247127, 249127, 251127, 253127, 257127, 260127, 261127, 264127, 267127, 270127, 272127, 274127, 276127, 288127, 300127, 304127, 313127, 315127, 317127, 333127, 334127, 336127, 339127, 341127, 343127, 368127, 371127, 376127, 379127, 382127, 396127, 398127, 401127, 405127, 433127, 435127, 438127, 464127, 466127, 468127, 470127, 471127, 473127, 474127, 485127, 488127, 490127, 492127, 495127, 513127 & 518127.

Why it was recalled

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Root cause (FDA determination)

Packaging change control

Action the firm took

Consignees were notified by letter on 06/06/2014.

Recalling firm

Firm

Teleflex Medical

Address

4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.

Timeline

Recall initiated

2014-06-05

Posted by FDA

2014-07-07

Terminated

2015-07-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #128063. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.