Fresenius Kabi Compounding, LLC Recalls

FDASep 25, 2024Nationwide• Fresenius Kabi Compounding, LLC

Phenylephrine HCl Injection (Fresenius Kabi) – Manufacturing Violations (2024)

CGMP violations

FDASep 25, 2024Nationwide• Fresenius Kabi Compounding, LLC

Phenylephrine HCl Injection (Fresenius Kabi) – Manufacturing Violations (2024)

cGMP violations

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FDA

Sep 25, 2024

Nationwide

• Fresenius Kabi Compounding, LLC

Oxytocin Injection (Fresenius Kabi) – Manufacturing Violations (2024)

cGMP violations

FDASep 25, 2024Nationwide• Fresenius Kabi Compounding, LLC

Thiamine HCl Injection (Fresenius Kabi) – Manufacturing Violations (2024)

cGMP violations

FDASep 25, 2024Nationwide• Fresenius Kabi Compounding, LLC

Ryaltris Nasal Spray (Glenmark) – Clogged Delivery System (2024)

Defective Delivery System: The dip tube is clogged causing the spray not to work.

FDASep 24, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Sour Charlie Bread (Salt City Baking) – Undeclared Wheat (2024)

Undeclared Gluten

Undeclared Wheat flour. Product contains wheat flour but product was sold without the Ingredients Statement.

FDASep 23, 2024IN, UT• Salt City Baking Company, LLC

Eleos Male-Female Midsection (Onkos Surgical) – Assembly Challenge (2024)

Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.

Low

FDASep 22, 2024Nationwide• Onkos Surgical, Inc.

Nihon Kohden SpO2 Ear Clip Sensor (Nihon Kohden) – FDA Approval Issue (2024)

Due to oximeters not having FDA market approval or clearance to distribute in the U.S.

FDASep 18, 2024AL, AZ, AR +26 more• Nihon Kohden America Inc

Nihon Kohden SpO2 Forehead Sensor (Nihon Kohden) – FDA Approval Issue (2024)

Due to oximeters not having FDA market approval or clearance to distribute in the U.S.

FDASep 18, 2024AL, AZ, AR +26 more• Nihon Kohden America Inc

Quantimetrix Urine Control Set (McKesson) – Packaging Temperature Risk (2024)

The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25C. This may lead to delay in patients' results.

Low

FDASep 17, 2024Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

Check-Flo Performer Introducer Set (Cook) – Shaft Connection Problem (2024)

Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.

FDASep 16, 2024Nationwide• Cook Incorporated

Enjoy Premium Coconut Cookies (KTM Services) – Undeclared Milk (2024)

Undeclared Allergen

Undeclared allergens; milk

Class IHigh

FDASep 13, 2024HI, IN, NV• KTM Services, Inc.

Enjoy Premium Taro Cookies (KTM Services) – Undeclared Milk (2024)

Undeclared Allergen

Undeclared allergens; milk

Class IHigh

FDASep 13, 2024HI, IN, NV• KTM Services, Inc.

BD Synapsys (Becton Dickinson) – Software Error (2024)

Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for organisms that do not have defined breakpoints in CLSI or EUCAST. This occurs when the identified organism is included in the same interpretive group as a species for which there is a specific breakpoint. May result in either a false susceptible or false resistant result. A false susceptible result can cause inadequate or incomplete antibiotic treatment due to the use of an ineffective antibiotic, and a false resistant result may limit access to a preferred antibiotic regimen with possible elongation of therapy

FDASep 12, 2024Nationwide• Becton Dickinson & Co.

AirJet HydroJet Spa Pumps (Bestway) – Fire Hazard (2024)

Fire/Burn Risk

The spa pumps could have been sold separately, or in a package with an inflatable spa liner in different colors, styles, and inflatable spa sizes. The inflatable spa liners packaged with the pumps are sold under the brand names SaluSpa, Coleman, and Hydro-Force, which are printed on the side of the liner. This recall only includes AirJet and HydroJet Spa Pump model numbers P05332, P05339, P05711, P05807, P07000, P07001, P05511, P07034, and P07572. "Bestway" and the model number are printed on the label on the side or back of the spa pump.

CPSCSep 12, 2024Nationwide• Bestway (Hong Kong) International Ltd., of China

GOETAS Pool Drain Covers – Entrapment Safety Issue (2024)

This recall involves GOETAS-branded drain covers that are sold for use in swimming pools. The white, plastic, main pool drain covers measure about 7 inches high and have top grates that measure about 9 inches in diameter.

CPSCSep 12, 2024Nationwide• GuangZhouShiYiYangKangTiSheBeiYouXianGongSi, dba GOETAS, of China

Berkeley Springs Water (Berkeley Club) – Coliform Contamination (2024)

Product tested positive for coliforms.

Class IIILow

FDASep 12, 2024IN, MD• Berkeley Club Beverages, Inc.

LINK Universal Handle (Waldemar Link) – Material Failure Risk (2024)

Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break in the middle.

FDASep 11, 2024Nationwide• Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkhausenweg 10 Hamburg Germany

Trail King TKHDG (Trail King) – Lift Cylinder Risk (2024)

Trail King Industries, Inc. (Trail King) is recalling certain 2019-2020 TKHDG Paver Special trailers. The gooseneck lift lower cylinder mount may fatigue and crack, which can cause the trailer to drop suddenly during the loading or unloading process.