Galt Centeze Catheter recalled for potential sterile barrier packaging defect
Galt Medical Corporation is recalling Centeze Catheters due to a potential open seal in sterile packaging. Affected catheters were distributed nationwide and internationally.
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: This FDA Class II recall involves a potential sterile barrier defect with a theoretical hazard and no reported illnesses or injuries. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, scoring 3 (High).
Plain-English summary
Galt Medical Corporation has issued a recall of the Centeze Catheter (catalog numbers DRC-002-05 and DRC-002-06) due to a potential open seal in the sterile barrier packaging. The affected catheters have been distributed nationwide in Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania, and Utah, as well as internationally in Canada, Ireland, Israel, Korea, Qatar, and the United Kingdom.
The Centeze Catheter is a medical device intended for use in percutaneous fluid aspirations and small volume drainage procedures in both adult and adolescent patients. An open seal in the sterile barrier packaging could potentially allow the device to become contaminated.
The recall affects approximately 2,881 catheters with lot numbers 25051843 (DRC-002-05) and 25034783 (DRC-002-06).
Healthcare facilities and patients who may have received these catheters should check their inventory and discontinue use if they have devices matching the affected lot numbers. Contact Galt Medical Corporation for instructions on product return or replacement.
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
- Hazard
- sterile-packaging-defect
- infection-risk
Distribution
Distributed nationwide across the United States.
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