Recall Z-0119-2018— Halyard Health, Inc
Class II · Terminated
Class II FDA medical device recall by Halyard Health, Inc, initiated 2017-10-06, terminated 2020-09-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case.. Reason: Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents..
- Recalling firm
- Halyard Health, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-10-06
- Terminated
- 2020-09-01
- Firm location
- Alpharetta, GA, United States
Product description
Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
Reason for recall
Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
Data sourced from openFDA. This site is unofficial and independent of the FDA.