Baxter MiniCap with Povidone-Iodine Solution Recalled for Sponge Defects
Baxter Healthcare is recalling MiniCap with Povidone-Iodine Solution units for hemodialysis because the product may have separating or protruding sponges.
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, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard involves a physical defect (separating sponges) in a medical device used for hemodialysis, posing a risk of harm without reported fatalities or serious injuries.
Plain-English summary
Baxter Healthcare Corp. is recalling 4,391,520 units of MiniCap with Povidone-Iodine Solution, item number 5C4466P, used for hemodialysis. The recall is due to a defect where the product may have separating or protruding sponges.
The affected lots are GD896845, GD897371, GD896936, GD897124, GD897165, GD897157, GD896944, and GD896837, with expiration dates ranging from October 2015 to December 2015. These products were distributed nationwide in the United States and in Canada, Austria, Norway, Portugal, Saudi Arabia, and Spain.
This is an FDA Class II recall. Healthcare providers and patients should stop using the affected units and contact Baxter Healthcare for further instructions.
The recalled product
- Product
- MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Medical Device — Hemodialysis
- Hazard
- Affected units
- 4,391,520
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 (12)
- Lot Numbers: GD896845
- Exp. 10/2015
- GD897371
- Exp. 01/2016
- GD896936
- GD897124
- Exp. 11/2015
- GD897165
- Exp. 12/2015
- GD897157
- GD896944
- GD896837
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Baxter Healthcare Corp.
See all →- HighBaxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
FDA (Devices) · 2017-09-20
- ModerateBaxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies
FDA (Devices) · 2016-12-07
- ModerateBaxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk
FDA (Devices) · 2016-12-07
- ModerateBaxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure
FDA (Devices) · 2016-12-07
- HighBaxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
FDA (Devices) · 2016-11-16
Same hazard · physical defect
See all →- HighThermodilution Catheter May Bend During Use, Causing Monitor Errors
FDA (Devices) · 2023-04-19
- ModerateBard Clean-Cath Intermittent Catheter Recalled for Packaging and Tip Defects
FDA (Devices) · 2021-04-28
- HighFerring Recalls ZOMA-Jet 5 Demonstration Kits Due to Defective Delivery System
FDA (Drugs) · 2021-04-07
- HighROi CPS Recalls Custom Procedure Packs with Flaking Gauze Sponges
FDA (Devices) · 2021-01-06
- HighGE Healthcare Recalls Flow Sensor Service Parts with Damaged Tubes
FDA (Devices) · 2020-11-11