Recall Z-0504-2015

Teleflex Medical · initiated September 3, 2014

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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.

Codes / lots: 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.

Reason for recall

Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor.

FDA-determined cause: Packaging change control

Action taken

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.

Details

Recall number
Z-0504-2015
Initiated
September 3, 2014
Posted by FDA
December 12, 2014
Terminated
August 14, 2017
Product code
CAF – Nebulizer (Direct Patient Interface)
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…
Recalling firm
Teleflex Medical, Durham, NC

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0505-2015 Class IIAqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070…Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility… 09/03/2014Terminated