Carefusion 2200 Manometer Recall Due to Compromised Sterile Packaging Integrity
Carefusion 2200 Inc is recalling 4,240 units of sterile manometers because the integrity of the sterile packaging is potentially compromised.
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 3/5 (High).
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 involves a sterile medical device where the integrity of the packaging is potentially compromised, creating a risk of harm (infection) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Carefusion 2200 Inc is recalling 4,240 units of Manometer, 550 ml three-Way Stopcock; STERILE. The recall is being conducted because the integrity of the sterile packaging is potentially compromised.
The affected products are identified by Product Code 4330 and Lot Codes 0000837810, 0000840335, 0000842213, 0000848531, 0000851181, and 0000853962. These units were distributed nationwide in the United States as well as in Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, and Vietnam.
Healthcare providers and consumers should stop using the affected manometers and contact Carefusion 2200 Inc for instructions on return or replacement.
The recalled product
- Product
- Manometer, 550 ml three-Way Stopcock; STERILE;
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 4,240
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 (6)
- Product Code: 4330 Lot Code: 0000837810
- 0000840335
- 0000842213
- 0000848531
- 0000851181
- 0000853962
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Carefusion 2200 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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