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Recall Observatory FDA recall evidence

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

July 17, 2013

Class II

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

    reason.no_named_rule · v1.0.0

    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.