Recall Z-1518-2015
Hospira Inc. · initiated February 27, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinician programmed and/or hospital defined medication limits.
Codes / lots: List Number: 20709; Serial Numbers: 15551001 , 15551002 , 15551003 , 15551004 , 15551005 , 15551007 , 15551009 , 15551010 , 15551011 , 15551012 , 15551013 , 15551014 , 15551015 , 15551016 , 15551017 , 15551018 , 15551019 , 15551020 , 15551021 , 15551022 , 15551023 , 15551024 , 15551025 , 15551026 , 15551028 , 15551029 , 15551030 , 15551031 , 15551032 , 15551033 , 15551034 , 15551035 , 15551036 , 15551037 , 15551038 , 15551039 , 15551040 , 15551041 , 15551043 , 15551044 , 15551045 , 15551046 , 15551047 , 15551048 , 15551049 , 15551050 , 15551051 , 15551052 , 15551053 , 15551054 , 15551055 , 15551056 , 15551057 , 15551058 , 15551059 , 15551060 , 15551061 , 15551062 , 15551063 , 15551064 , 15551065 , 15551066 , 15551067 , 15551068 , 15551069 , 15551070 , 15551071 , 15551073 , 15551074 , 15551075 , 15551076 , 15551077 , 15551078 , 15551079 , 15551080 , 15551081 , 15551082 , 15551083 , 15551084 , 15551085 , 15551086 , 15551087 , 15551088 , 15551089 , 15551090 , 15551091 , 15551092 , 15551093 , 15551094 , 15551095 , 15551096 , 15551097 , 15551098 , 15551099 , 15551100 , 15551101 , 15551102 , 15551103 , 15551104 , 15551105 , 15551106 , 15551107 , 15551108 , 15551109 , 15551110…
Reason for recall
The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.
FDA-determined cause: Device Design
Action taken
Hospira will contract with Stericycle Inc., in Indianapolis, IN to send letters and a reply form to Hospira customers. Receipt of the letters will be confirmed by the UPS tracking. Customers will be requested to return a reply form to Stericycle indicating the number of pumps on hand and that they have received the letter and notified the users. For questions regarding this recall call 800-441-4100.
Details
- Recall number
- Z-1518-2015
- Initiated
- February 27, 2013
- Posted by FDA
- April 23, 2015
- Terminated
- November 7, 2016
- Product code
- MEA – Pump, Infusion, Pca
- Quantity
- 38,882
- Distribution
- Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico, American Virgin Islands; and Internationally to Canada.
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1517-2015 Class II | The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia…The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in… | 02/27/2013Terminated |