Hospira PCA 3 Infusion Pump Recall for Occlusion Detection Failure
Hospira is recalling 8,216 PCA 3 infusion pumps because normal wear on a component may prevent the device from detecting distal occlusions, a defect that resulted in one 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 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 8,216 PCA 3 infusion pump systems. These devices are used in various clinical settings, including general floors, operating rooms, and critical care units, to allow clinicians or patients to administer analgesia within programmed limits.
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 to foreign locations. Hospitals and healthcare facilities should check their inventory against the provided list of serial numbers to identify affected units.
The recalled product
- Product
- The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partum, burn unit, medical surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), and pediatrics. The PCA 3…
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 8,216
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. 12384
- Serial Numbers: 12920041
- 12920048
- 12920052
- 12920056
- 12920066
- 12920069
- 12920079
- 12920082
- 12920101
- 12920102
- 12920104
- 12920105
- 12920106
- 12920107
- 12920117
- 12920121
- 12920122
- 12920152
- 12920158
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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- SevereBaxter Infusion Pump Recalled for Improper Testing Documentation
FDA (Devices) · 2018-05-16
- SevereHospira Recalls LifeCare PCA Infusion Systems Due to Occlusion Detection Failure
FDA (Devices) · 2016-07-20
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