The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within cli
FDA device recall Z-1517-2015 · posted 2015-04-23 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MEA
- Quantity affected
- 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
- Date initiated
- 2013-02-27
- Date posted
- 2015-04-23
- Date terminated
- 2016-11-07
- Location
- Lake Forest, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 (K043256) | Hospira, Inc. | 2004-12-06 |