FDA (Devices) recall action 87998

Fresenius Medical Care Holdings, Inc. recalled 9 products on 2021-07-28

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2021-07-28
Critical: 0
Units: 185

Why these products were recalled

Exposed to freezing temperatures due to refrigerated truck malfunctions

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–9 of 9

HighFDA (Devices)··2021-07-28
Hemodialysis Acid Concentrates Recalled After Freezing Exposure During Transport
Fresenius Medical Care is recalling Citrasate and GranuFlo Dry Acid Concentrates after freezing temperature exposure during refrigerated truck transport. Affected lots distributed in Texas should be discontinued immediately.
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
Category
Distribution
1 state
HighFDA (Devices)··2021-07-28
Fresenius APD Luer-Lock Adapter Recalled Due to Freezing Temperature Exposure
Fresenius Medical Care is recalling 5 cases of the APD Luer-Lock Adapter (Lot 20LR08111) distributed in Texas after exposure to freezing temperatures during truck transport. Freezing may have compromised device sterility and functionality.
Product
The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, N
Category
Distribution
1 state
ModerateFDA (Devices)··2021-07-28
Liberty Drain Line Recalled for Freezing Temperature Exposure During Transport
Fresenius Medical Care is recalling 6 cases of 026-20036A Liberty Drain Lines distributed in Texas due to exposure to freezing temperatures during refrigerated truck malfunction.
Product
026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting
Category
Distribution
1 state
HighFDA (Devices)··2021-07-28
Fresenius Sterile Stay Safe Cap Recalled for Freezing Temperature Exposure
Fresenius recalls 39 cases of Sterile Stay Safe Caps (lot numbers B1ZH191, B1ZI092) distributed to Texas due to exposure to freezing temperatures during refrigerated truck malfunction, which may have compromised product sterility.
Product
050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Use Fresenius Sterile Stay Safe¿ Cap is intended to be used for closure of the s
Category
Distribution
1 state
HighFDA (Devices)··2021-07-28
MTS Set dialysis accessory recalled for freezing temperature exposure during transport
Fresenius is recalling MTS Sets distributed to Texas due to exposure to freezing temperatures from refrigerated truck malfunctions. This exposure may compromise the sterility of the device.
Product
The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in
Category
Distribution
1 state
HighFDA (Devices)··2021-07-28
Medical dialysis concentrates recalled for freezing temperature exposure
Fresenius Medical Care recalls Citrasate and NaturaLyte hemodialysis acid concentrates due to exposure to freezing temperatures during refrigerated truck transport. The affected products were distributed exclusively to Texas.
Product
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid 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 us
Category
Distribution
1 state
HighFDA (Devices)··2021-07-28
Drain Bag Set for Peritoneal Dialysis Exposed to Freezing During Transport
A Drain Bag Set used in peritoneal dialysis was exposed to freezing temperatures due to refrigerated truck malfunction during distribution. The affected lot was distributed to Texas.
Product
The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather than letting the effluent flow directly to a drain. The Drain Bag Set connects t
Category
Distribution
1 state
HighFDA (Devices)··2021-07-28
Hemodialysis concentrate recalled for freezing exposure during transport
Fresenius Medical Care recalls Granuflo and Naturalyte hemodialysis concentrate affected by freezing temperatures during refrigerated truck transport. Freezing may compromise product sterility and safety.
Product
(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting GRANUFLO & NATURALYTE: Concentrate is formulated to be used in conjunct
Category
Distribution
1 state
HighFDA (Devices)··2021-07-28
NaturaLyte Bicarbonate Concentrate Recalled After Freezing Temperature Exposure
NaturaLyte Dry Bicarbonate Concentrate, used in hemodialysis machines to prepare dialysate, was recalled after exposure to freezing temperatures during transport. The affected lot (21ATBC004) was distributed to facilities in Texas only.
Product
NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is formula
Category
Distribution
1 state