Hospira LifeCare Pump Model 4200 PCA Infuser Recalled for Occlusion Detection Failure
Hospira is recalling 6,268 LifeCare Pump Model 4200 PCA Infusers because they may fail to detect distal occlusions, a defect that caused one serious injury.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that one report resulted in a serious injury, which meets the rubric criteria for a score of 4 (Severe) regarding significant injury reports.
Plain-English summary
Hospira Inc. is recalling 6,268 LifeCare Pump Model 4200 PCA Infuser systems. These devices are used for patient-controlled analgesia, allowing health care professionals to set prescribed doses, rates, and limits for drug infusion. The pumps are designed with mechanical, electrical, and software safeguards to prevent patient injury or drug abuse.
The recall is due to reports that the pumps failed to detect distal occlusions. This issue is caused by normal wear and tear on the Half Nut, a component that travels up and down the lead screw. This wear prevents the device from properly detecting the pressure build-up associated with a distal occlusion. One of these failures resulted in a serious injury.
The affected units were distributed nationwide to all 50 states, the District of Columbia, Puerto Rico, and the Virgin Islands, as well as foreign markets. Health care facilities and users should check their serial numbers against the list provided in the official recall notice to determine if their devices are affected.
The recalled product
- Product
- The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 6,268
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 No. 0F782
- Serial Numbers: 100
- 101
- 102
- 105
- 106
- 107
- 108
- 109
- 111
- 112
- 114
- 116
- 117
- 119
- 120
- 121
- 122
- 123
- 124
Distribution
Part of a larger recall action
This product is one of 4 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.
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