Hospira Recalls LifeCare PCA Plus II Infusion Pumps Due to Occlusion Detection Failure
Hospira is recalling 53,151 LifeCare PCA Plus II infusion pumps because wear on a component may prevent the detection of distal occlusions, resulting in serious injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 source text explicitly states that one report of the defect resulted in a serious injury, which meets the rubric criteria for a score of 4 (Severe).
Plain-English summary
Hospira Inc. is recalling 53,151 units of the LifeCare PCA Plus II infusion pump system. These devices are designed for the delivery of analgesic medication through intravenous or epidural routes in various clinical settings, including intensive care units, trauma units, and oncology centers.
The recall is being conducted because the pumps may fail 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. Hospira has received reports of this failure, one of which resulted in a serious injury.
The affected pumps were distributed nationwide to all 50 states, the District of Columbia, Puerto Rico, and the Virgin Islands, as well as to foreign markets. Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall documentation.
The recalled product
- Product
- The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units…
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 53,151
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. 1950
- Serial Numbers: 5815
- 10002
- 10015
- 10057
- 10067
- 10087
- 10095
- 10096
- 10099
- 10101
- 10107
- 10109
- 10111
- 10112
- 10118
- 10122
- 10123
- 10125
- 10128
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.
See all 4 products in this recall →Related recalls
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