Class 1 Device Recall Stay Safe Catheter Extension Sets and stay"safe/Luer Lock Adapter

• Date Initiated by Firm: January 23, 2024
• Date Posted: March 26, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1325-2024
• Recall Event ID: 94084
• 510(K)Number: K022412 K173593
• Product Classification: Set, administration, for peritoneal dialysis, disposable - Product Code KDJ
• Product: stay-safe /Luer Lock Catheter Ext. 12 in
• Code Information: Model Number: 050-95004; UDI/DI (Bag): 00840861100781; UDI/DI (Case): 10840861100788; All lots.
• Recalling Firm/ Manufacturer: Fresenius Medical Care Holdings, Inc.; 920 Winter St Bld 920; Waltham MA 02451-1521
• For Additional Information Contact: Global Medical Information and Education Office; 855-616-2309
• Manufacturer Reason for Recall: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
• FDA Determined Cause: Device Design
• Action: 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
• Quantity in Commerce: 663,221 eaches
• Distribution: Domestic: Nationwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KDJ; 510(K)s with Product Code = KDJ