Recall record at a glance
| Official record | Z-2823-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Merit Medical Systems, Inc. |
| Report date | Aug 22, 2018 |
| Recall initiation date | Dec 20, 2017 |
| Location | South Jordan, UT, United States |
Official product description
Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the FlexNeck PD Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC System of peritoneoscopic implantation enable inspection of the peritoneum to confirm the presence of adhesions and to avoid them, all patients who are suitable for PD can receive this catheter.
Why the product was recalled
Mix-up between adult and pediatrics PD catheter.
Distribution information
Worldwide Distribution - US Nationwide in the states of AL, CA, DE, FL, KY, MA, MO, NC, NY, OH, PA, and UT and the countries of Germany
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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