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

FDA device recall Z-0457-2014 · posted 2013-12-06 · Terminated

Recall details

Recalling firm

Hospira Inc.

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

GCX

Quantity affected

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

Date initiated

2013-07-17

Date posted

2013-12-06

Date terminated

2016-12-06

Location

Lake Forest, IL