Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulize
FDA device recall Z-0504-2015 · 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
- CAF
- 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
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