Hospira Acclaim Encore Infusion Pump Recall for Broken Door Assemblies
Hospira is recalling 13,218 Acclaim Encore infusion pumps because broken door assemblies may prevent proper closure, causing unrestricted flow or therapy delays.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"
Plain-English summary
Hospira Inc. is recalling 13,218 Hospira Acclaim Encore infusion pumps due to a defect in the door assemblies. The pumps are designed to deliver parenteral infusions, including whole blood or red blood cell components, and enteral fluids.
The recall is being issued because the door assemblies may break. If a door assembly breaks, it may prevent the door from closing properly, which could result in unrestricted flow. Additionally, if the door cannot be closed, the pump cannot be used, potentially resulting in a delay in therapy.
The affected pumps were distributed nationwide to facilities in 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. Users should check their pump serial numbers against the list provided in the official recall notice to determine if their device is affected.
The recalled product
- Product
- Hospira Acclaim Encore 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.
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 13,218
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- List Number: 12237
- Serial Numbers: 12670196
- 12670182
- 12670203
- 12670281
- 12671061
- 12671058
- 12671175
- 12718477
- 12672450
- 12672413
- 12716099
- 12716071
- 12671563
- 12672061
- 12672079
- 12672156
- 12718948
- 12717835
- 12716259
Distribution
Part of a larger recall action
This product is one of 2 recalled by Hospira Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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