Snoqualmie Gourmet Ice Cream Recalls

Coconut Rum Sorbet is being recalled due to the potential to be contaminated with Listeria monocytogenes

FDADec 21, 2014Nationwide• Snoqualmie Gourmet Ice Cream

Coconut Sorbet, sold under Snoqualmie brand. Product is ... (Snoqualmie Gourmet Ice Cream) – Listeria contamination (2014)

Coconut Sorbet is being recalled due to the potential to be contaminated with Listeria monocytogenes

FDADec 21, 2014Nationwide• Snoqualmie Gourmet Ice Cream

Passion Fruit Sorbet, sold under Snoqualmie brand. Produ... (Snoqualmie Gourmet Ice Cream) – Listeria contamination (2014)

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Listeria

Passion Fruit Sorbet is being recalled due to the potential to be contaminated with Listeria monocytogenes.

Class IHigh

FDADec 21, 2014Nationwide• Snoqualmie Gourmet Ice Cream

10% Soft-Serve Vanilla Ice Cream Mix, sold under Snoqualm... (Snoqualmie Gourmet Ice Cream) – Listeria contamination (2014)

10% Soft-Serve Vanilla Ice Cream Mix is being recalled because finished product tested positive for Listeria monocytogenes.

FDADec 21, 2014Nationwide• Snoqualmie Gourmet Ice Cream

Ice Cream products, total 177 different flavors. Product... (Snoqualmie Gourmet Ice Cream) – Listeria contamination (2014)

All 177 flavors ice cream products are being recalled due to the potential to be contaminated with Listeria monocytogenes.

FDADec 21, 2014Nationwide• Snoqualmie Gourmet Ice Cream

Bean Bag Chairs (Comfort Research) - Entrapment risk (2014)

This recall involves vinyl polystyrene-filled bean bag chairs with a single zipper on the exterior cover. The round vinyl bean bag chairs measure 88 and 98 inches in diameter. Colors and patterns included in the recall are black, hot pink, lime, purple, royal blue, ruby red, and baseball, basketball, football and soccer ball. A tag sewn into bean bag chair's cover seam reads "Made By Comfort Research" and "100% Polystyrene."

CPSCDec 19, 2014Nationwide• Comfort Research, LLC, of Grand Rapids, Mich.

BD 10 mL Syringe (Becton Dickinson) – stopper misalignment (2014)

The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe.

FDADec 19, 2014Nationwide• Becton Dickinson & Company

Anti-Lambda APC-H7 (BD Biosciences) – antibody contamination (2014)

Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.

FDADec 19, 2014Nationwide• BD Biosciences, Systems & Reagents

Clinpro 5000 Toothpaste (3M) – Missing Lot Number (2014)

Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..

Class IIILow

FDADec 19, 2014Nationwide• 3M Company/3m Espe Dental Products

IntelliVue Information Center (Philips Medical Systems) – alarm disable risk (2014)

Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification

FDADec 19, 2014Nationwide• Philips Medical Systems, Inc.

CD8 PE Diagnostic (BD Biosciences) – contamination issue (2014)

One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.

FDADec 19, 2014Nationwide• BD Biosciences, Systems & Reagents

Circuit Breakers (Schneider Electric) – electrical safety (2014)

Fire/Burn Risk

The recall involves PowerPact J-frame molded case circuit breakers with thermal-magnetic trip units. The circuit breakers are made of black plastic and have a three-position breaker handle that indicates whether the breaker is off, on or tripped. The recalled circuit breakers are rated for 150 to 250 amps, have interruption ratings of D, G, J, L and R. They were manufactured in two pole and three pole configurations with either lug-in/lug-out or plug-in (I-Line) style connectors. Brand name "Schneider Electric" or "Square D" is on a yellow sticker above the breaker handle and on the top of a label on the side of the circuit breaker. A label on the front of the circuit breaker to the left of the breaker handle has the catalog number at the top. The number also appears on a label on the side of the breaker. Schneider Electric catalog numbers begin with "NJ" and Square D catalog numbers begin with "J." A label on the front of the circuit breaker to the right of the breaker handle has the date code in the lower right corner. Recalled circuit breakers were manufactured from March 26, 2014 through September 26, 2014 and have date codes 14131 through 14395. The date codes are in the YYWWD format (example: 14131 = year 2014, week 13, day of the work week 1/ Monday). Breakers with following catalog numbers are being recalled: Catalog Number Breaker Type (N)JDX26XXX 2 Pole (N)JGX26XXX 2 Pole (N)JJX26XXX 2 Pole (N)JLX26XXX 2 Pole (N)JDX36XXX 3 Pole (N)JGX36XXX 3 Pole (N)JJX36XXX 3 Pole (N)JLX36XXX 3 Pole (N)JRX36XXX 3 Pole

CPSCDec 18, 2014Nationwide• Schneider Electric USA Inc., of Columbia, Mo., and Tlaxcala, Mexico

Cobas KRAS Mutation Kit (Roche Molecular Systems) – invalid result generation (2014)

cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.

Class IIILow

FDADec 18, 2014Nationwide• Roche Molecular Systems, Inc.

Merlin@home Transmitter (St Jude Medical) – software reset risk (2014)

Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Quadra Assura ICDs and Assurity and Allure Pacemakers.

FDADec 18, 2014Nationwide• St Jude Medical Cardiac Rhythm Management Division

Virtua West Jersey TPN (Central Admixture) – Microbial Risk (2014)

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

FDADec 17, 2014Nationwide• Central Admixture Pharmacy Services, Inc.

MEDPOR BARRIER Sheets (Stryker) – implant deformation risk (2014)

Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.

FDADec 17, 2014Nationwide• Stryker Craniomaxillofacial Division

Colorado Springs TPN Neonate (Central Admixture) – Microbial Risk (2014)

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

FDADec 17, 2014Nationwide• Central Admixture Pharmacy Services, Inc.

TPN Neonatal Starter Bag (Central Admixture) - non-sterile risk (2014)

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

FDADec 17, 2014Nationwide• Central Admixture Pharmacy Services, Inc.

Entertainer's Secret Throat Relief (Tropichem) - microbial contamination (2014)

E. coli

Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli

FDADec 17, 2014IN, NY• Tropichem Research Labs, Inc.

MEDPOR TITAN MAX Implant (Stryker) – incorrect article packaging (2014)

Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained article #81035 MEDPOR Titan Max OFW - MTB - Left. The appropriate articles were actually included in the shipment. However, the products had an incorrect barrier location.