GALT Centeze Catheter recalled due to potential sterile packaging seal failure
Galt Medical Corporation is recalling 2,881 GALT Centeze Catheters due to a potential open seal in the sterile barrier packaging. The open seal could compromise sterility of the device.
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 3/5 (High).
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: FDA Class II recall of a medical device where the potential hazard is sterility compromise, which represents a risk of harm (infection). The source text does not report any illnesses or injuries, making this a theoretical risk scenario that falls under the High category per the rubric.
Plain-English summary
Galt Medical Corporation is recalling 2,881 GALT Centeze Catheters (Catalog Numbers DRC-002-05 and DRC-002-06) due to a potential open seal in the sterile barrier packaging. The Centeze Catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures for adult and adolescent patients.
The recalled catheters were distributed nationwide in Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania, and Utah, as well as internationally to Canada, Ireland, Israel, Korea, Qatar, and the United Kingdom. Lot Numbers 25051843 (DRC-002-05) and 25034783 (DRC-002-06) are affected.
A compromised sterile barrier could allow the device to become non-sterile prior to use, potentially increasing the risk of infection. Patients or healthcare providers who have received or used these catheters should contact their healthcare provider or Galt Medical Corporation with any questions or if they have concerns about their treatment.
The recalled product
- Product
- GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.
- Manufacturer
- Galt Medical Corporation
- Category
- Medical Device — Catheter
- Affected units
- 2,881
Distribution
Part of a larger recall action
This product is one of 7 recalled by Galt Medical 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.
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