Z-0457-2014 Class II Terminated
FDA device recall Z-0457-2014 was initiated by Hospira Inc. on Jul 17, 2013 and is designated Class II. 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. The recall status is terminated (terminated Dec 6, 2016). Affected quantity: 3,560 units distributed from June 2004 - December 2012.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 18, 2013
- Initiation Date
- Jul 17, 2013
- Termination Date
- Dec 6, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,560 units distributed from June 2004 - December 2012
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.
Distribution Pattern
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.
Code Information
*** DOMESTIC PRODUCT *** List Numbers: 43449-04-11 and 43449-04-01; Lot Numbers: All; *** FOREIGN PRODUCT *** List Numbers: 0L21297W1, 0L2129701, 0L2139701, 43449001L, 434490101, 434490102, 434490181, 434490181, 434490182, 4344901DX, 434496101, 434496161, 4344961A1, 434499090; Lots: All
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0457-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026