Recall record at a glance
| Official record | Z-1482-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | Hospira Inc. |
| Report date | May 7, 2014 |
| Recall initiation date | Oct 31, 2013 |
| Quantity | 13,218 infusion pumps total |
| Location | Lake Forest, IL, United States |
Official product description
Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
Why the product was recalled
Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy.
Distribution information
Nationwide Distribution -- AK, AL, AR, AZ, CA, CO, CR, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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