Gaws Gourmet Foods Recalls

undeclared sesame

Ropivacaine HCl Injection (STAQ Pharma) – Leaking Bags (2023)

STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.

FDANov 29, 2023Nationwide• STAQ Pharma, Inc.

Salami & Cheese Bagel (Gaws) - Undeclared Sesame (2023)

undeclared sesame

1...155 156157158 159...1251

Page 157 of 1251Next

Class IIModerate

FDANov 29, 2023MI• Gaws Gourmet Foods

Classic Italian Sub (Gaws Gourmet) – Undeclared Sesame (2023)

undeclared sesame

Deluxe Italian Sub (Gaws Gourmet) – Undeclared Sesame (2023)

undeclared sesame

XL Ham & Cheese Sub (Gaws) - Undeclared Sesame (2023)

undeclared sesame

FDANov 28, 2023IN, MI• XTANT Medical Holdings, Inc

Cortera Spinal Fixation System (XTANT) – Screw Shank Incorrect (2023)

Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.

Low

Patient Information Center (Philips) – Push Notification Failure (2023)

Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.

FDANov 28, 2023Nationwide• Philips North America

EDS 3 CSF Drainage System (Natus) – Sterility Concern (2023)

Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.

FDANov 28, 2023Nationwide• Natus Medical Incorporated

Scoot Control R-net (mo-Vis) – Throttle Lever Stuck (2023)

In rare cases, the lever of the throttle can get temporarily stuck during the movement and does not come back to its neutral point by itself. If this happens during usage, an unwanted movement of the chair could be the result. An unwanted movement could result in damage to the wheelchair, material damage around the chair and/or injury to the user, attendant or by-standers.

FDANov 28, 2023TN, TX• mo-Vis BVBA Biebuyckstraat 15D Nevele Belgium

External Drainage Collection Bag (Natus) – Sterility Concern (2023)

Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.

FDANov 28, 2023Nationwide• Natus Medical Incorporated

CareEvent Monitor (Philips) – Push Notification Failure (2023)

Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.

FDANov 28, 2023Nationwide• Philips North America

RAM 4500 – Steering Control Module Issue (2023)

Chrysler (FCA US, LLC) is recalling certain 2023 Ram 1500 Classic, Ram 3500 Classic, 3500 Cab Chassis, 2023-2024 Ram 2500, 4500/5500 Cab Chassis, and Ram 3500 vehicles. The steering column control module may cause the high beams to activate when the turn signal is used or activate the turn signal when the high beams are used. In addition, the turn signal self-canceling feature may not function properly. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."

NHTSANov 28, 2023Nationwide• RAM

RibLoc U Plus 90 Instrument – Potential Breakage (2023)

Due to potential breakage during use.

FDANov 27, 2023Nationwide• Acumed LLC

Actim PROM Dipstick – Lubricant Interference (2023)

Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false positive result.

FDANov 23, 2023Nationwide• ACTIM OY Klovinpellontie 3 Espoo Finland

Fujifilm Mobile X-Ray System – Incorrect Default Settings (2023)

When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected.