Recall Z-0207-2014
Hospira Inc. · initiated February 5, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Codes / lots: List No. 12391; Serial Numbers: 13840001 , 13840002 , 13840003 , 13840004 , 13840005 , 13840006 , 13840007 , 13840008 , 13840009 , 13840010 , 13840011 , 13840012 , 13840013 , 13840014 , 13840015 , 13840016 , 13840017 , 13840018 , 13840019 , 13840020 , 13840021 , 13840022 , 13840023 , 13840024 , 13840025 , 13840026 , 13840027 , 13840028 , 13840029 , 13840030 , 13840031 , 13840032 , 13840033 , 13840034 , 13840035 , 13840036 , 13840037 , 13840038 , 13840039 , 13840040 , 13840041 , 13840042 , 13840043 , 13840044 , 13840045 , 13840046 , 13840047 , 13840048 , 13840049 , 13840050 , 13840051 , 13840052 , 13840053 , 13840054 , 13840055 , 13840056 , 13840057 , 13840058 , 13840059 , 13840060 , 13840061 , 13840062 , 13840063 , 13840064 , 13840065 , 13840066 , 13840067 , 13840068 , 13840069 , 13840070 , 13840071 , 13840072 , 13840073 , 13840074 , 13840075 , 13840076 , 13840077 , 13840078 , 13840079 , 13840080 , 13840081 , 13840082 , 13840083 , 13840084 , 13840085 , 13840086 , 13840087 , 13840088 , 13840089 , 13840090 , 13840091 , 13840092 , 13840093 , 13840094 , 13840095 , 13840096 , 13840097 , 13840098 , 13840099 , 13840100 , 13840101 , 13840102 , 13840103 , 13840104 , 13840105 , 13840106…
Reason for recall
Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not
FDA-determined cause: Nonconforming Material/Component
Action taken
Hospira sent an URGENT DEVICE FIELD CORRECTION letter dated February 5, 2013 was sent to all direct accounts notifying them of the issue. For device users who experience these issues, Hospira recommends the following actions be taken: 1) Remove the pump from service and perform a Performance Verification Test (PVT) Distal Occlusion Test to determine if the distal pressure sensor is performing correctly. 2) If the device does not pass the PVT, it may indicate that the distal pressure sensor has drifted. Perform the appropraite troubleshooting and repair activities defined by the user's facility, whihc may include returning the device to Hospira for further diagnosis and servicing. The remediation for this issue is to perform a recalibration of the distal pressure sensor. Hospira also intends to release in 2013 a recommendation of a yearly test to determine if the distal pressure sensor's calibration has drifted. Customers who suspect that their device(s) may be affected by this issue are urged to contact Hospira at 1-800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) to report the issue. Hospira will provide loaner devices if necessary. Customers are requested to complete and return the reply form included with the notification letter per the instructions on the reply form. For questions regarding this recall call 224-212-2000.
Details
- Recall number
- Z-0207-2014
- Initiated
- February 5, 2012
- Posted by FDA
- November 14, 2013
- Terminated
- November 14, 2016
- Product code
- FRN – Pump, Infusion
- Quantity
- List No. 12391: 182,970 units
- Distribution
- Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, 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, SI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Croatia, Dominican Republic, Turks and Caicos.
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0203-2014 Class II | Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+…Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following… | 02/05/2012Terminated |
| Z-0204-2014 Class II | Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A+ Infusion Systems…Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following… | 02/05/2012Terminated |
| Z-0205-2014 Class II | Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A+ Infusion Systems…Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following… | 02/05/2012Terminated |
| Z-0206-2014 Class II | Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: The Plum A+ Infusion…Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following… | 02/05/2012Terminated |
| Z-0208-2014 Class II | Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A+ Infusion Systems…Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following… | 02/05/2012Terminated |
| Z-0209-2014 Class II | *** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use…Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following… | 02/05/2012Terminated |