Z-0457-2014Class II

Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of...

Name: Z-0457-2014 Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of...
Creator: Hospira Inc.
Published: 2013-07-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-07-17 / Terminated / root cause: manufacturing process

FDA source

Hospira Inc. began a recall of 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... on 2013-07-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0457-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-17
Posted: 2013-12-06
Terminated: 2016-12-06
Recalling firm: Abbott Medical
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.
Product code: GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An URGENT DEVICE RECALL letter dated July 17, 2013 was mailed to direct consignees. The letter requested the consignees: 1) quarantine any affected products, 2) complete and return the reply form included with the letter, 3) notify healthcare professionals within the consignee's organization of the recall, 4) return the affected products to Stericycle in accordance with the instructions in the letter. Consignees are further requested to forward a copy of the notification materials to any customers that they may have distributed the products to.
Quantity in commerce: 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.
Product codes and lots: *** 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0457-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0457-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-06

Product code GCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)