PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 18, 2013 Initiated: July 17, 2013 #Z-0457-2014

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.

Details

Recalling Firm
Hospira Inc.
Units Affected
3,560 units distributed from June 2004 - December 2012
Distribution
Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NY, PA, SD, TX, UT, VA, and WA and countries of: Canada and EMEA.
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Hospira Inc.. Units affected: 3,560 units distributed from June 2004 - December 2012.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 18, 2013. Severity: Moderate. Recall number: Z-0457-2014.