Merit Medical catheter extractor kits recalled for syringe quality defects
Merit Medical is recalling 3,631 catheter extractor convenience kits due to defective syringes with leaks and breakage. The identified quality issues may compromise patient safety during catheter removal.
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 is an FDA Class II recall of a medical device with identified quality defects (leaks and breakage) that may pose a risk to patient safety. No hospitalizations or injuries are reported in the source material, making this a risk-of-harm product where potential injury has not yet been documented, fitting the 'High' severity category per the rubric.
Plain-English summary
Merit Medical Systems, Inc. is recalling 3,631 catheter extractor convenience kits that contain defective plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. The recalled models include Outake CET200 and CET300 kits. Leaks, breakage, and other quality issues have been identified in the syringes that may pose a risk to patient health.
The Catheter Extractor is a medical device accessory intended for the minimally invasive removal of tunneled, long-term hemodialysis catheters. The defective syringes are component parts included in the Merit Medical convenience kits.
The affected kits have been distributed nationwide across the United States. Patients and healthcare providers with these kits should refer to the specific lot numbers listed in the FDA recall notice to identify whether their kits are affected.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Outake, REF CET200 and CET300, The Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters. T
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 3,631
Distribution
Part of a larger recall action
This product is one of 23 recalled by Merit Medical Systems, Inc. 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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