RecallRadar

FDA Device recall Z-0457-2014

Product is labeled in part: LIST NO. 43449

On 2013-12-18 the FDA classified a Class II recall of Product is labeled in part: LIST NO. 43449 by Hospira, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0457-2014
ClassificationClass II
Statusterminated
Initiated2013-07-17
Published2013-12-18
Last updated2026-09-13 11:53 UTC
CompanyHospira
DistributionUS

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.

Identifiers

code_info
*** DOMESTIC PRODUCT *** List Numbers: 43449-04-11 and 43449-04-01; Lot Numbers: All; *** FOREIGN PRODUCT ***…*** 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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0457-2014%22

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