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stay.safe recallZ-1325-2024 · Fresenius Medical Care Holdings, Inc. · initiated Jan 23, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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

Recall details

Recall number
Z-1325-2024
Status
Open, Classified
Initiated by the company
Jan 23, 2024
Posted by the FDA
Mar 26, 2024
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
663,221 eaches
Product code
KDJ
FDA submissions
K022412, K173593
Distribution
Domestic: Nationwide Distribution.

Product description

stay-safe /Luer Lock Catheter Ext. 12 in

Code information (models, lots, serial numbers)

Model Number: 050-95004; UDI/DI (Bag): 00840861100781; UDI/DI (Case): 10840861100788; All lots.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K022412, K173593 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94084).

Sources and updates

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