Recall Z-0457-2014— Hospira Inc.
Class II · Terminated
Class II FDA medical device recall by Hospira Inc., initiated 2013-07-17, terminated 2016-12-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Forest, IL 60045 USA. Used to isolate suction waste during surgeries, or to clear patient airways, throat or wounds to allow treatment.. Reason: Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be achieved due to the canister and liner not properly seating..
- Recalling firm
- Hospira Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-17
- Terminated
- 2016-12-06
- Firm location
- Lake Forest, IL, United States
Product description
Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Forest, IL 60045 USA. Used to isolate suction waste during surgeries, or to clear patient airways, throat or wounds to allow treatment.
Reason for recall
Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be achieved due to the canister and liner not properly seating.
Data sourced from openFDA. This site is unofficial and independent of the FDA.