Recall Z-0504-2015— Teleflex Medical
Class II · Terminated
Class II FDA medical device recall by Teleflex Medical, initiated 2014-09-03, terminated 2017-08-14. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor..
- Recalling firm
- Teleflex Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-03
- Terminated
- 2017-08-14
- Firm location
- Durham, NC, United States
Product description
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.
Reason for recall
Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor.
Data sourced from openFDA. This site is unofficial and independent of the FDA.