Recall Z-1324-2024

Reason for recall

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

FDA-determined cause: Device Design

Action taken

IMPORTANT MEDICAL DEVICE CORRECTION Letter were sent to customer on February 14, 2024 informing customers that non-dioxin-like polychlorinated biphenyl acids (PCBAs) could leach from the stay-safe Catheter Extension sets and Adapter, which are manufactured using peroxide cross-linked silicone tubing. Please note that PCBAs are chemically different from polychlorinated biphenyls (PCBs) which were not identified. No complaints have been reported. PCBA levels decrease with shorter catheter extension sets and decrease over the treatment time. PCBA exposure threshold examples were provided per body weight (less than 10kg and between 10 and 40 kg), treatment length and various device combinations. Patients with body weight greater than 40kg are not impacted. FMCRTG recommends the following for Healthcare providers until an update to the catheter extension silicone material becomes available: 1. Use only the shortest length extension set (6-inch, Part No. 050-95013) when treating patients with a body weight below 40 kg, including infants and neonates. 2. Remain alert for further updates and recommendations from the FMCRTG and FDA. 3. Please report any complaints or adverse events to product.complaints@fmcna.com or FDA MedWatch at https://www.fda.gov/safety/medical-product-safetyinformation/medwatch-forms-fda-safety-reporting. For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309. ***Update 04/10/2024*** A revised Medical Device Correction Letter and Poster were sent to customers via email recommending the following for Healthcare providers until an update to the catheter extension silicone material becomes available: 1. Use only the shortest length extension set (6-inch, Part No. 050-95013) when treating patients with a body weight below 40 kg, including infants and Neonates and if possible, avoid using the adapter. This is for both existing patients and patients about to initiate peritoneal dialysis. Re