—#187621

Product

Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.

FDA product code: KPO — Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K192209
Affected lot / code info: Lot Number/UDI: (1) 21ATGF013 (01)00884086110135 0FD3251-3B (2) 20SXGF010 (01)00840861101597 0FD3251-3B (3) 20SXGF013 (01)00840861101597

Why it was recalled

Exposed to freezing temperatures due to refrigerated truck malfunctions

Root cause (FDA determination)

Environmental control

Action the firm took

Fresenius issued telephone script communication on April 28.2021 stating reason for recall, heath risk and action to take: Tell them you already contacted their Home Therapy Nurse to alert them that you would be calling them. o The purpose of my call today is that you received a delivery from us on (either Feb 22nd or Feb 23rd). o The truck you received a delivery from had a temperature malfunction due to the bad storms Texas experienced back in February. This caused the product you were delivered to be exposed to freezing or near freezing temperatures for about 3 hours. o o I see you received on . o (if received any PD SOLUTION/SALINE/or CONCENTRATES): Explain that the solutions inside their product are not affected and that we have freeze/thaw studies that prove this. Explain that due to the freezing temperatures, the packaging may become compromised, and they may have seen leaks. For the other products such as Hand Sanitizer and other ancillary products, again, the product could be compromised according to their packaging requirements listed on their packaging. o We are giving you the opportunity to return these products if you choose to do so at this time. o If returning product(s): o Fill out RGA spreadsheet with customer information including how much product they are returning (include lot# and amount returning). Driver will pick up returned products on their next scheduled visit. Fresenius Corrections and Removals Rep: Email Post Market Surveillance to open a complaint against product. o If not returning product(s): o Thank them for their time and reiterate to always inspect their packaging for leaks as this is what they are trained to do anyways from their Home Therapies Nurse. If you have any questions call 781-699-2243 or email: beth.st.germain@fmc-na.com

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Bld 950, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: US Distribution to: TX only

Timeline

Recall initiated: 2021-04-28
Terminated: 2022-08-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187621. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.