CareFusion Recalls VersaSafe Plastic Cannulas Due to Packaging Punctures
CareFusion 303, Inc. is recalling 1,546,800 units of VersaSafe Plastic Cannulas because punctures were detected in the blister packaging during the manufacturing process.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a packaging defect (punctures in blister packaging) detected during the process, with no reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
CareFusion 303, Inc. is recalling 1,546,800 units of VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200. These medical devices are used with secondary IV sets or syringes to administer fluids and medications through a needle or catheter inserted into a patient's artery or vein.
The recall was initiated because punctures were detected in the blister packaging during the packaging process. The affected lots are 1470303001, 1570314802, 1470303002, 1570317701, 1470304601, 1570317702, 1470306602, 1570317703, 1470306301, 1570317704, 1470306602, 1570322001, 1470311301, 1660771501, 1470306301, 1470311302, and 1470314801.
The products were distributed worldwide, including in the United States states of Colorado, Illinois, Indiana, Maryland, Michigan, New York, Ohio, and Texas, as well as in Australia, New Zealand, and Japan. Healthcare facilities and consumers should stop using these specific lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or catheter inserted into a patients artery or vein.
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — IV Cannula
- Hazard
- Affected units
- 1,546,800
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 (15)
- Lot No. 1470303001
- 1570314802
- 1470303002
- 1570317701
- 1470304601
- 1570317702
- 1470306602
- 1570317703
- 1470306301
- 1570317704
- 1570322001
- 1470311301
- 1660771501
- 1470311302
- 1470314801
Distribution
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