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Actionable records answer all three decision questions. Limited records remain available and clearly identify missing official information.

Limited official informationPatient-Relevant Medical Devices

Pediatric care bed

If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that the patient (child) or third parties (children) will operate the hand...

AffectedPediatric care bed; Product Designation: KayserBett IDA;
RiskIf the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key wh...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro...

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap m...

AffectedPhilips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 w...
RiskDuring the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark im...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo,...

Some of the Calibration/Output Certificates had the outputs reversed.

AffectedPhothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, P...
RiskSome of the Calibration/Output Certificates had the outputs reversed.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationFood

SECOND NATURE KETO CRUNCH SMART MIX, 10-ounce retail-sized plastic pouch, UPC 077034013405, 6-10oz units per case.

The product may contain undeclared allergens (cashews, pistachios), and dried cherries.

AffectedSECOND NATURE KETO CRUNCH SMART MIX, 10-ounce retail-sized plastic pouch, UPC 077034013405, 6-10oz units per case.
RiskThe product may contain undeclared allergens (cashews, pistachios), and dried cherries.
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% wit...

These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspe...

AffectedSpinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), B...
RiskThese procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacain...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationFood

STRAUS FAMILY CREAMERY Cookie Dough ORGANIC SUPER PREMIUM ICE CREAM ONE PINT (473mL) Produced and Distributed by Straus Family Creamery,...

Potential contamination with foreign objects (metal pieces).

AffectedSTRAUS FAMILY CREAMERY Cookie Dough ORGANIC SUPER PREMIUM ICE CREAM ONE PINT (473mL) Produced and Distributed by Stra...
RiskPotential contamination with foreign objects (metal pieces).
ActionNot available

Missing from associated official evidence: action.

Limited official informationFood

UPC 21788400000 Ready Meals SANDWICH TUNA SALAD CROISSANT SS COLD This is Albertson's store-made item and sold by unit at point of sale w...

Contains statement does not declare TUNA; Contains statement does not declare Tuna

AffectedUPC 21788400000 Ready Meals SANDWICH TUNA SALAD CROISSANT SS COLD This is Albertson's store-made item and sold by uni...
RiskContains statement does not declare TUNA; Contains statement does not declare Tuna
ActionNot available

Missing from associated official evidence: action.

Limited official informationFood

UPC 23168600000 SHRIMP 41-50 P&D With CILANTRO LIME MARINADE 5% This is Albertson's store-made item and sold by random weight at point of...

Contains statement does not declare Shrimp and Anchovy

AffectedUPC 23168600000 SHRIMP 41-50 P&D With CILANTRO LIME MARINADE 5% This is Albertson's store-made item and sold by rando...
RiskContains statement does not declare Shrimp and Anchovy
ActionNot available

Missing from associated official evidence: action.