Curity I.V. Start Kit Recalled Due to Supplier Component Issue
Covidien is recalling Curity I.V. Start Kits because a supplier recalled a povidone-iodine applicator used in the kits.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text does not report any illnesses, injuries, or deaths, and the recall is driven by a supplier component issue without explicit mention of a high-risk pathogen or structural defect.
Plain-English summary
On March 26, 2013, Covidien LLC received a recall notice from its supplier, CareFusion. CareFusion is recalling a variety of over-the-counter drug products, including the 10% Povidone Iodine SEPP Applicator. This applicator is utilized in specific convenience kits, including the Curity I.V. Start Kit (Product IDs 80530 and 8508).
The recall involves 17,740 kits that were distributed worldwide, including nationwide in the USA and in Panama. Specific lot codes for Product 80530 include 032887164, 203184264, 110983764, 208286764, 116480564, 221590564, 120987864, 236385564, and 127085464. Specific lot codes for Product 8508 include 207383964 and 23489464.
Consumers and healthcare facilities should check their inventory for these specific product IDs and lot codes. If the affected kits are found, they should be removed from use and returned to the supplier or manufacturer as directed by the recall notice.
The recalled product
- Product
- Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.
- Manufacturer
- Covidien LLC
- Category
- Medical Device — IV Start Kits
- Affected units
- 17,740
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 (11)
- Product 80530: 032887164
- 203184264
- 110983764
- 208286764
- 116480564
- 221590564
- 120987864
- 236385564
- 127085464
- Product 8508: 207383964
- 23489464
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Covidien LLC 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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Similar recalls
- ModerateCareFusion Recalls Povidone Iodine Applicators Due to Sterility Labeling Errors
FDA (Drugs) · 2013-04-03
- SevereMedline Recalls IV Start Kits With Subpotent Povidone-Iodine
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