—#122385

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.

FDA product code: GCX — Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: *** 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

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

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.

Timeline

Recall initiated: 2013-07-17
Posted by FDA: 2013-12-06
Terminated: 2016-12-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122385. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.