Recall Z-1517-2015 ยท MEA Pump, Infusion, Pca
Hospira Inc.
The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits.
| Date | Apr 23, 2015 (initiated Feb 27, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 8,214 units |
| 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; an |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043256 | HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 Hospira, Inc., Dec 6, 2004 |