Hospira PCA 3 Infusion Pump Recalled for Door Design Flaw
Hospira is recalling 8,214 PCA 3 infusion pumps because the clear plastic door design allows excessive flexing, permitting unauthorized access to medication vials.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves unauthorized access to medication, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Hospira Inc. is recalling 8,214 units of the PCA 3 infusion pump. The device is designed to allow clinicians or patients to administer analgesia safely within programmed limits. The recall is due to a design defect in the clear plastic door, which allows for excessive flexing. This flexing permits unauthorized access to the vial of medication.
The affected units were distributed worldwide, including all 50 U.S. states, the District of Columbia, Puerto Rico, the American Virgin Islands, and Canada. A specific list of serial numbers for the affected units is available in the recall documentation.
Hospira is the recalling firm. Consumers and healthcare facilities should check their PCA 3 infusion pumps against the provided serial number list to determine if they are affected. If a unit is affected, it should be removed from service and returned to Hospira for repair or replacement.
The recalled product
- Product
- The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits.
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 8,214
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 12384: Serial Numbers: 12920041
- 12920048
- 12920052
- 12920056
- 12920066
- 12920069
- 12920079
- 12920082
- 12920101
- 12920102
- 12920104
- 12920105
- 12920106
- 12920107
- 12920117
- 12920121
- 12920122
- 12920152
- 12920158
- 12920159
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.
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