Z-1323-2024Class I

stay-safe /Safe Lock Catheter Ext. 12 in

Name: Z-1323-2024 stay-safe /Safe Lock Catheter Ext. 12 in
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2024-01-23
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2024-01-23 / Open, Classified / root cause: design

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of stay-safe /Safe Lock Catheter Ext. 12 in on 2024-01-23. FDA classified it as Class I and gives the reason as "The peroxide cross-linked tubing has leachables identified as NDL PCBAs". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1323-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-01-23
Posted: 2024-03-26
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: stay-safe /Safe Lock Catheter Ext. 12 in
Product code: KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Reason for recall: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Root cause tag: design
FDA root 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 [email protected] 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: 114,982 eaches
Distribution: Domestic: Nationwide Distribution.
Product codes and lots: Model Number: 050-95001; UDI/DI (Bag): 00840861100767; UDI/DI (Case): 10840861100764; All lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1323-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1323-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-26
Z-1324-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-26
Z-1325-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-26
Z-1326-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-26
Z-1327-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-26

Product code KDJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)