Device recall: Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .

FDA enforcement event 68493 · Class II · initiated 5 Jun 2014 · status Terminated · terminated 2 Jul 2015

DeviceVoluntary: Firm initiated15 product recordsDurham, NC

FDA enforcement event 68493 is a device recall by Teleflex Medical of Durham, NC, initiated 5 Jun 2014 and classified Class II, with 15 product records.

FDA defines Class II as 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.

Status: Terminated, terminated 2 Jul 2015. Initiation: voluntary: firm initiated. Teleflex Medical has 82 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Teleflex Medical, Durham, NC.

Reason for recall

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

Distribution

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

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2003-2014	Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .	7,758,650 ea. (total for all types listed)	Class II	Terminated	16 Jul 2014
Z-2004-2014	Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .	7,758,650 ea. (total for all types listed)	Class II	Terminated	16 Jul 2014
Z-2005-2014	Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor	7,758,650 ea. (total for all types listed)	Class II	Terminated	16 Jul 2014
Z-2006-2014	Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.	7,758,650 ea. (total for all types listed)	Class II	Terminated	16 Jul 2014
Z-2007-2014	Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.	7,758,650 ea. (total for all types listed)	Class II	Terminated	16 Jul 2014
Z-2008-2014	Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.	7,758,650 ea. (total for all types listed)	Class II	Terminated	16 Jul 2014
Z-2009-2014	Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.	7,758,650 ea. (total for all types listed)	Class II	Terminated	16 Jul 2014
Z-2010-2014	Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.	7,758,650 ea. (total for all types listed)	Class II	Terminated	16 Jul 2014
Z-2011-2014	Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.	7,758,650 ea. (total for all types listed)	Class II	Terminated	16 Jul 2014
Z-2012-2014	Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.	7,758,650 ea. (total for all types listed)	Class II	Terminated	16 Jul 2014
Z-2013-2014	Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.	7,758,650 ea. (total for all types listed)	Class II	Terminated	16 Jul 2014
Z-2014-2014	Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.	7,758,650 ea. (total for all types listed)	Class II	Terminated	16 Jul 2014
Z-2015-2014	Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor.	7,758,650 ea. (total for all types listed)	Class II	Terminated	16 Jul 2014
Z-2016-2014	Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor.	7,758,650 ea. (total for all types listed)	Class II	Terminated	16 Jul 2014
Z-2017-2014	Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier adaptor.	7,758,650 ea. (total for all types listed)	Class II	Terminated	16 Jul 2014

Context

91%of 2014 device events are Class II1,176 events that year

15product records in this eventfirm median: 1

82events on this register for the firm

Other enforcement events for Teleflex Medical

Initiated	Product (first record)	Type	Class	Records
30 Oct 2019	HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are in	Device	Class II	1
8 Oct 2019	Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage: T	Device	Class II	3
4 Oct 2019	WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are de	Device	Class II	2
30 Jul 2019	Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tu	Device	Class I	8
1 Jul 2019	Rusch EasyCath Kit	Device	Class II	1
24 May 2019	Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management	Device	Class I	8
10 May 2019	Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF 870-07KI	Device	Class I	1
1 Apr 2019	RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0	Device	Class II	5
27 Feb 2019	Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500	Device	Class III	2
14 Jan 2019	RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device	Device	Class III	2

All 82 events for Teleflex Medical

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "The seals of the adaptor packaging may be creased which may potentially affect packaging integrity."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 2 Jul 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.