Device 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.
Z-0457-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 66431
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,560 units distributed from June 2004 - December 2012
- Official record key
device-enforcement:Z-0457-2014
Official wording
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.
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
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.
Derived failure modes
-
Unknown
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.