Agency classClass IIOur severity:Severe FDA (Devices)·Z-2142-2016·Announced 2016-07-20

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.

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 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
Hazard: occlusion-detection-failure
serious-injury
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

Distributed nationwide across the United States.

The notice also names 53 states specifically:

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 →

Same manufacturer · Hospira Inc.

See all →

Critical
Hospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
Moderate
Hospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
Low
Hospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
Severe
Hospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
High
Hospira Symbiq Infusion Pump Recall for White Screen Safety Shutdown
FDA (Devices) · 2016-11-16

Same hazard · occlusion detection failure