Recall Z-0505-2015 ยท OGG Humidifier Nebulizer Kit
Teleflex Medical
Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428; Aquapak 728 SW, 760 ML W/028 Adaptor, Product No. 037-28; Aquapak SW/EAU Sterile, 760 ML W/Adaptor, Product No. 037-28C; Aquapak 728 SW, 760 ML W/28 Adaptor, French, Product No. 037-02F; Aquapak 733 SW, 7
| Date | Dec 12, 2014 (initiated Sep 3, 2014) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.