Baxter MiniCap with Povidone-Iodine Solution Recalled for Leaking Pouches
Baxter Healthcare is recalling 629,280 units of MiniCap with Povidone-Iodine solution for dialysis due to leaking pouches. The recall is voluntary and nationwide.
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 for a medical device used in dialysis. While no specific injuries or illnesses are reported in the source text, the defect (leaking pouches) poses a risk of harm to patients, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is voluntarily recalling 629,280 units of MiniCap with Povidone-Iodine solution, catalog number 5C4466P. These medical devices are intended for dialysis to isolate the Easy-Lock connector of the solution transfer set. The recall was initiated on May 21, 2013, and distributed nationwide.
The reason for the recall is leaking pouches. The FDA classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The recall was initiated by the firm and is currently terminated.
Patients and healthcare providers should stop using the affected MiniCap devices with Lot Number GD893891. Baxter Healthcare notified customers via letter. The recall was terminated on July 14, 2016.
The recalled product
- Product
- Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock connector of the solution transfer set.
- Manufacturer
- Baxter Healthcare Corp.
- Hazard
- Affected units
- 629,280
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)
- Lot Number GD893891
Distribution
Distributed nationwide across the United States.
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