Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product N

FDA device recall Z-0505-2015 · posted 2014-12-12 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

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

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.

Root cause

Packaging change control

Status

Terminated

Product code

OGG

Quantity affected

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, N

Date initiated

2014-09-03

Date posted

2014-12-12

Date terminated

2017-08-14

Location

Durham, NC