Centurion Medical Blood Draw Kit Recalled for Iodine Assay Deficiency
Centurion Medical Products Corporation is recalling Blood Draw Kits because the PVP Prep Pad does not meet required iodine levels for shelf life.
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 describes a shelf-life/assay issue without reporting any illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Centurion Medical Products Corporation is recalling Blood Draw Kits distributed nationally. The recall involves specific lot codes: 2016032890, 2016091290, and 2016112890.
The recall was initiated because the Convenience Kit contains a PVP Prep Pad that does not meet the iodine assay level required to support the 36-month shelf life. This is a Class II recall, indicating a situation that could temporarily cause adverse health consequences or where the probability of serious adverse health consequences is remote.
Consumers and suppliers should stop using the affected kits and contact the recalling firm for further instructions.
The recalled product
- Product
- BLOOD DRAW KIT
- Manufacturer
- Centurion Medical Products Corporation
- Hazard
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 (1)
- IV4285 Lot codes: 2016032890 2016091290 2016112890
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 21 recalled by Centurion Medical Products Corporation 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 21 products in this recall →Related recalls
Same manufacturer · Centurion Medical Products Corporation
See all →- HighCenturion Difficult IV Kit Recalled for False Carboxyhemoglobin Results
FDA (Devices) · 2020-07-15
- HighCenturion ENT Snuffer Kit Recalled for Incomplete Sterile Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Chest Tube Trays Recalled for Incomplete Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Pitcher Kits Due to Seal Defects
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Hyperalimentation and Dressing Change Trays
FDA (Devices) · 2020-02-12
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighCenturion Port Draw Kit Recalled Due to Incomplete Sterile Package Seals
FDA (Devices) · 2020-02-12
- SevereCenturion Medical Recalls High Drainage LVAD Tray Kits Due to Packaging Concerns
FDA (Devices) · 2019-08-14
- HighCenturion Medical Recalls LVAD Dressing Kits Due to Sterile Packaging Concerns
FDA (Devices) · 2019-08-14
- SevereMedline Centurion maintenance flush kits recalled for sterility failure
FDA (Devices) · 2024-03-06
- HighCenturion Medical Recalls Post-Operative Ophthalmic Dressing Kits Due to Sterility Concerns
FDA (Devices) · 2017-04-12
- SevereMedical maintenance flush kits recalled for potential sterility defect
FDA (Devices) · 2024-03-06