FDA Medical Device Recalls (openFDA)
Teleflex Medical: Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulizer Adaptor 028, Sterile, Shelfpak, Product No. 031-28 & 031-28F, Aqaupak Nebulizer Adaptor 033, Sterile, Shelfpak, Product No. 031-33; Aqaupak Nebulizer Adaptor 033, Sterile, Japanese, Product No. 031-33J. Used in anesthesiology.
- Recall number
- Z-0504-2015
- Recalling firm
- Teleflex Medical
- Product
- Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulizer Adaptor 028, Sterile, Shelfpak, Product No. 031-28 & 031-28F, Aqaupak Nebulizer Adaptor 033, Sterile, Shelfpak, Product No. 031-33; Aqaupak Nebulizer Adaptor 033, Sterile, Japanese, Product No. 031-33J. Used in anesthesiology.
- Status
- Terminated
- Initiated
- 2014-09-03
- Posted
- 2014-12-12
- Terminated
- 2017-08-14
- Reason
- Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor.
- Root cause
- Packaging change control
- Action
- Customers were notified of the recall by letter on September 3, 2014. The letter requested that they discontinue distribution and quarantine the products and return the products to Teleflex. The letter also requested a sub-recall.
- Quantity
- 3,193,548 ea
- Distribution
- Worldwide Distribution-US (nationwide) including Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY, and the countries of United Arab Emirates, Australia, Belgium, Brazil, Canada, Chile, China, France, Great Britain, Japan, India, Indonesia, Israel, South Korea, Mexico, Philippines, Saudi Arabia, Singapore, Taiwan, Thailand, Uruguay, and Zambia.
- Lot, serial or model codes
- Product No. 043128, Lot # 02E1200719, 02E1200720, 02E1201281, 02F1200964, 02K1201946, 02E1201808, 02E1203097, 02G1300256, 02G1301048, & 02M1201691; Product No. 403133, Lot # 02E1201282, 02K1201948, 02F1200965, 02L1201194, 02M1200230, & 02F1302063; Product No. 031-28, Lot # 02D1202234, 02A1202383, 02A1202382, 02B1201069, 02D1200247, 02D1200248, 02D1201944, 02D1202274, 02D1202733, 02D1202236, 02D1202734, 02D1202735, 02D1202233, 02G1200664, 02G1200678, 02G1201016, 02G1201698, 02F1200961, 02G1200676, 02M1200585, 02L1200927, 02M1200749, 02M1201693, 02A1300194, 02A1300457, 02D1301655, 02D1301191, 02D1300864, 02D1301192, 02D1302730, 02F1301742, 02E1302765, 02F1300739, 02F1302062, & 02D1200249; Product No. 031-28F, Lot # 02E1200717, 02K1201947, 02F1200962, & 02E1202197; Product No. 031-33, Lot # 02E1200718, 02A1202384, 02E1202198, 02F1200963, 02G1200666, 02J1202240, 02M1200584, 02M1200748, 02M1201771, 02D1302731, 02A1300458, 02B1300718, & 02M1201692; Product No. 031-33J, Lot # 02D1202258, 02D1202260, 02D1202259, 02D1202261, 02E1201563, 02E1201279, 02E1203866, 02M1200747, 02B1300717, 02B1301203, 02E1301554, 02B120342, 02J1201473, 02J1202736, 02F1201179, & 02M1200057.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAF
- Firm FEI
- 3005747797
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28