Recall Z-0457-2014 ยท GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Hospira Inc.
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.
| Date | Dec 6, 2013 (initiated Jul 17, 2013) |
| Status | Terminated |
| 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. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.