July 2015 recalls

1,183 recalls were announced in July 2015.

What the numbers show

Critical: 342
Severe: 255
High: 333
Moderate: 232
Low: 21

Of the 1,183 recalls this month scored against our rubric, 29% are Critical, 22% are Severe.

Which agencies issued them

601–700 of 1183

SevereFDA (Drugs)·D-1159-2015·2015-07-08
Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns
Lincare, Inc. is recalling TPN 3:1 bags compounded by United Medical IV Center because the sterility of the product is not assured.
Product
TPN 3:1, 3000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes Famotidine, MgSO4, KCL, NaC, Zinc Cl; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Vitamin K, Ascorbic Acid, Rx Only. Compounded by…
Category
Drug
Distribution
1 state
SevereFDA (Food)·F-1570-2015·2015-07-08
Snoqualmie Gourmet Ice Cream Recalled for Potential Listeria Contamination
Snoqualmie Gourmet Ice Cream is recalling 177 ice cream flavors due to potential Listeria monocytogenes contamination. Products were distributed nationwide.
Product
Ice Cream products, total 177 different flavors. Products sold under brand names such as Emerald & Spruce, Snoqualmie, and Top Pot. Products are packaged in various sizes as described below: 1 gallon horizontal Tray; 1.5 gallon Tub; 4.69 oz. single serve Cup; 16 oz.…
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1191-2015·2015-07-08
Lincare Recalls Vancomycin HCl Bags Due to Sterility Concerns
Lincare, Inc. is recalling Vancomycin HCl bags compounded by United Medical IV Center because the sterility of the product is not assured.
Product
Vancomycin HCl, Vancomycin 1500mg / D5W 265mL, Qty: 2 265 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1196-2015·2015-07-08
Lincare Recalls Vancomycin Bags Due to Sterility Assurance Concerns
Lincare, Inc. is recalling 2 bags of Vancomycin 750 mg/NS 100 ml compounded by United Medical IV Center because the sterility of the product is not assured.
Product
Vancomycin 750 mg/NS 100 ml accuflo, Packaged in 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1192-2015·2015-07-08
Lincare Recalls Vancomycin HCl/Heparin Due to Sterility Concerns
Lincare, Inc. is recalling Vancomycin HCl/Heparin compounded by United Medical IV Center because the sterility of the product is not assured.
Product
Vancomycin HCl/Heparin, Vancomycin 50mcg/mL / Heparin 100u/mL, Qty: 3, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereNHTSA·15V438000·2015-07-08
Navistar Recalls 2013-2015 International TranStar Trucks for Fire Risk
Navistar is recalling 2013-2015 International TranStar vehicles because a vent tube may detach, allowing engine oil to contact hot surfaces and cause a fire.
Product
INTERNATIONAL — INTERNATIONAL TRANSTAR
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·F-1546-2015·2015-07-08
Snoqualmie Sorbet Recalled for Potential Listeria Contamination
Snoqualmie Gourmet Ice Cream is recalling Sorbet Cosmo Lemon Twist due to potential Listeria monocytogenes contamination. The product was distributed nationwide.
Product
Sorbet Cosmo Lemon Twist, sold under Snoqualmie brand. Product is sold in 1.5 gallon plastic tubs. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1904-2015·2015-07-08
Palindrome HSI Chronic Catheters Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.
Product
Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1888-2015·2015-07-08
Recall of Palindrome Precision SI Chronic Catheters Due to Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall covers 72,363 units in the US and 24,631 internationally.
Product
Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1867-2015·2015-07-08
Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
Product
Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066C
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1547-2015·2015-07-08
Snoqualmie Strawberry Basil Sorbet Recalled for Listeria Risk
Snoqualmie Gourmet Ice Cream is recalling Strawberry Basil Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide.
Product
Strawberry Basil Sorbet, sold under Snoqualmie brand. Product is sold in 1.5 gallon plastic tubs. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1457-2015·2015-07-08
Snoqualmie 14% Ice Cream Mix Recalled for Potential Listeria Contamination
Snoqualmie Gourmet Ice Cream is recalling 14% Ice Cream Mix due to potential Listeria monocytogenes contamination. The product was distributed nationwide.
Product
14% Ice Cream Mix (with soy lecithin), sold under Snoqualmie brand. Product is sold in 2.5 gallon clear flexible plastic bags. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1473-2015·2015-07-08
Snoqualmie Custard Mix Recalled for Potential Listeria Contamination
Snoqualmie Gourmet Ice Cream is recalling 2.5-gallon bags of Custard Mix due to the potential for Listeria monocytogenes contamination.
Product
Custard Mix, sold under Snoqualmie brand. Product is sold in 2.5 gallon plastic bags. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1523-2015·2015-07-08
Snoqualmie Mango Sorbet Recalled for Potential Listeria Contamination
Snoqualmie Gourmet Ice Cream is recalling Mango Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 1.5 and 3 gallon tubs.
Product
Mango Sorbet, sold under Snoqualmie brand. Product is sold in 1.5 and 3 gallon plastic tubs. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1522-2015·2015-07-08
Snoqualmie Mango Passion Fruit Sorbet Recalled for Listeria Contamination
Snoqualmie Gourmet Ice Cream is recalling Mango Passion Fruit Sorbet due to contamination with Listeria monocytogenes. The product was distributed nationwide.
Product
Mango Passion Fruit Sorbet, sold under Snoqualmie brand. Product is sold in 1.5 and 3 gallon plastic tubs, in addition to a quantity of unknown sizes. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1198-2015·2015-07-08
Lincare Recalls Potassium Chloride IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling specific lots of Potassium Chloride IV bags because the sterility of the product is not assured.
Product
Potassium Chloride, Dextrose 5% LR 1000 mL with 40mEq KCL, Qty: 1 1000 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1175-2015·2015-07-08
Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling Fluorouracil 1200mg IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
Product
Fluorouracil 1200mg / D5W 274mL, Qty: 1 274 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Food)·F-1475-2015·2015-07-08
Snoqualmie Double Chocolate Custard with Espresso Recalled for Listeria Risk
Snoqualmie Gourmet Ice Cream is recalling Double Chocolate Custard with Espresso due to potential Listeria monocytogenes contamination.
Product
Double Chocolate Custard with Espresso, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1161-2015·2015-07-08
Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns
Lincare, Inc. is recalling TPN 3:1 bags compounded by United Medical IV Center because the sterility of the product is not assured.
Product
TPN 3:1, 1750 mL Bags, Qty: 5, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes Famotidine, KCL, K Phos, Na Acetate, MgSO4, NaCl; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Vitamin K, Rx Only. Compounded by: United…
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1189-2015·2015-07-08
Lincare Recalls Ceftriaxone Sodium Due to Sterility Concerns
Lincare, Inc. is recalling compounded Ceftriaxone Sodium IV bags because the sterility of the product is not assured. The recall affects units distributed in Arkansas.
Product
Ceftriaxone Sodium, Ceftriaxone 2gm / NS 50mL, Qty: 12 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1174-2015·2015-07-08
Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling Fluorouracil 4800mg IV bags compounded in Arkansas because the sterility of the product is not assured.
Product
Fluorouracil 4800mg / D5W 296mL, Qty: 1 296 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1163-2015·2015-07-08
Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns
Lincare, Inc. is recalling TPN 3:1 bags compounded in Arkansas between May 14 and May 27, 2015, because the sterility of the product is not assured.
Product
TPN 3:1, 1050 mL Bags, Qty: 6, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes KCL, K Phos, MgSO4, NaCl, Zinc Cl, Ca Gluconate; Vitamins, trace elements and medications Trace Ele.-Ped, Infuvite Pediat, Carnitor, Rx Only. Compounded by…
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1168-2015·2015-07-08
Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling Fluorouracil IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
Product
Fluorouracil 5760mg / D5W 265mL Qty: 1 265 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1152-2015·2015-07-08
Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns
Lincare, Inc. is recalling TPN 3:1 bags compounded between May 14 and May 27, 2015, because the sterility of the product is not assured.
Product
TPN 3:1, 2400 mL Bag, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj.; Electrolytes KCL, K Acetate, Na Acetate, K Phos, MgSO4; Vitamins, trace elements and medications Trace Ele. -Ped, Multi Vitamin, Rx Only, Compounded by: United…
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1166-2015·2015-07-08
Lincare Recalls Penicillin G Potassium IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling Penicillin G Potassium IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
Product
Penicillin G Potassium 5.4 MU/SW 240 mL AccuFlo, Qty: 4 240 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-1894-2015·2015-07-08
Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1201-2015·2015-07-08
Lincare Recalls Ceftazidime IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling compounded Ceftazidime IV bags because the sterility of the product is not assured.
Product
Ceftazidime 2 gm / NS 50mL, Qty: 15 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1170-2015·2015-07-08
Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling Fluorouracil IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
Product
Fluorouracil 1400mg / D5W 278mL Qty: 1 278 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Food)·F-1502-2015·2015-07-08
Snoqualmie Coconut Pineapple Sorbet Recalled for Listeria Risk
Snoqualmie Gourmet Ice Cream is recalling Coconut Pineapple Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide.
Product
Coconut Pineapple Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1182-2015·2015-07-08
Lincare Recalls Compounded Vancomycin and Heparin Due to Sterility Concerns
Lincare, Inc. is recalling compounded Vancomycin and Heparin products because the sterility of the product is not assured. The recall affects products distributed in Arkansas.
Product
VANC 50MCG/ML-HEP 100U/ML in 2ML, Packed in 2 mL Units, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Food)·F-1469-2015·2015-07-08
Snoqualmie Cherry Vanilla Custard Recalled for Listeria Risk
Snoqualmie Gourmet Ice Cream is recalling Cherry Vanilla Custard (without egg) due to potential Listeria monocytogenes contamination.
Product
Cherry Vanilla Custard (without egg), sold under Snoqualmie brand. Product is sold in 1.5 and 3 gallon plastic tubs. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1153-2015·2015-07-08
Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns
Lincare, Inc. is recalling TPN 3:1 bags compounded between May 14 and May 27, 2015, because the sterility of the product is not assured.
Product
TPN 3:1, 2250 mL Bags, Qty: 5, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, Intralipid 20%, Water for Inj; Electrolytes KCL, K Phos, Famotidine, Na Acetate, MgSO4; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only. Compounded by…
Category
Drug
Distribution
1 state
SevereFDA (Food)·F-1480-2015·2015-07-08
Snoqualmie French Vanilla Custard Recalled for Listeria monocytogenes
Snoqualmie Gourmet Ice Cream is recalling French Vanilla Custard due to the presence of Listeria monocytogenes. The product was distributed nationwide in 1.5 and 3 gallon tubs.
Product
French Vanilla Custard (with soy lecithin), sold under Snoqualmie brand. Product is sold in 1.5 and 3 gallon plastic tubs. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1197-2015·2015-07-08
Lincare Recalls Vancomycin IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling Vancomycin 1000mg IV bags compounded by United Medical IV Center in Arkansas because the sterility of the product is not assured.
Product
Vancomycin 1000mg / NS 100mL, Packaged in 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Food)·F-1532-2015·2015-07-08
Snoqualmie Pear Champagne Sorbet Recalled for Listeria Risk
Snoqualmie Gourmet Ice Cream is recalling Pear Champagne Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 3-gallon tubs.
Product
Pear Champagne Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1499-2015·2015-07-08
Snoqualmie Blueberry Sorbet Recalled for Potential Listeria Contamination
Snoqualmie Gourmet Ice Cream is recalling Blueberry Sorbet due to the potential for Listeria monocytogenes contamination. The product was distributed nationwide in 1.5 and 3 gallon tubs.
Product
Blueberry Sorbet, sold under Snoqualmie brand. Product is sold in 1.5 and 3 gallon plastic tubs. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1542-2015·2015-07-08
Snoqualmie Raspberry Sorbet Recalled for Potential Listeria Contamination
Snoqualmie Gourmet Ice Cream is recalling Raspberry Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide.
Product
Raspberry Sorbet, sold under Snoqualmie brand. Product is sold in 1 gallon plastic trays; 1.5 and 3 gallon plastic tubs. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1186-2015·2015-07-08
Lincare Recalls Vancomycin HCl / Heparin Due to Sterility Concerns
Lincare, Inc. is recalling Vancomycin HCl / Heparin compounded by United Medical IV Center because the sterility of the product is not assured.
Product
Vancomycin HCl / Heparin, Vancomycin 50mcg/ml / HEPARIN 100u/ml, Qty: 8, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Food)·F-1489-2015·2015-07-08
Snoqualmie Apple Cider Sorbet Recalled for Listeria Risk
Snoqualmie Gourmet Ice Cream is recalling Apple Cider Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 3-gallon tubs.
Product
Apple Cider Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1165-2015·2015-07-08
Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns
Lincare, Inc. is recalling TPN 3:1 bags compounded in May 2015 because the sterility of the product is not assured.
Product
TPN 3:1, 1844 mL Bags, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, Intralipid 20%, Water for Inj; Electrolytes KCL, Ca Gluconate, MgSO4, K Phos; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only. Compounded by: United Medical…
Category
Drug
Distribution
1 state
SevereFDA (Food)·F-1459-2015·2015-07-08
Snoqualmie Ice Cream Mix Recalled for Potential Listeria Contamination
Snoqualmie Gourmet Ice Cream is recalling 14% Ice Cream Mix due to potential Listeria monocytogenes contamination.
Product
14% Ice Cream Mix with acme stabilizer, sold under Snoqualmie brand. Product is sold in 2.5 gallon clear flexible plastic bags. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1873-2015·2015-07-08
Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Failure
Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications.
Product
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064CP
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1566-2015·2015-07-08
Snoqualmie Pistachio Gelato Recalled for Listeria Contamination Risk
Snoqualmie Gourmet Ice Cream is recalling Pistachio Gelato due to potential Listeria monocytogenes contamination. The product was distributed nationwide in various container sizes.
Product
Pistachio Gelato, sold under Snoqualmie Ice Cream brand. Product is sold in 1 gallon plastic trays; 1.5 and 3 gallon plastic tubs and other unknown container type/sizes. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1173-2015·2015-07-08
Lincare Recalls Ceftriaxone Sodium IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling Ceftriaxone Sodium IV bags because the sterility of the product is not assured. The affected units were distributed in Arkansas.
Product
CEFTRIAXONE SODIUM 2000mg / NS 50mL, Qty:4 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Food)·F-1567-2015·2015-07-08
Snoqualmie Pumpkin Gelato Recalled for Potential Listeria Contamination
Snoqualmie Gourmet Ice Cream is recalling Pumpkin Gelato due to the potential for Listeria monocytogenes contamination. The product was distributed nationwide in 3-gallon tubs.
Product
Pumpkin Gelato, sold under Snoqualmie Ice Cream brand. Product is sold in 3 gallon plastic tubs. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1494-2015·2015-07-08
Snoqualmie Berry Sorbet Recalled for Potential Listeria Contamination
Snoqualmie Gourmet Ice Cream is recalling Berry Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 1-gallon trays.
Product
Berry Sorbet, sold under Snoqualmie brand. Product is sold in 1 gallon plastic trays. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-2786-2015·2015-07-08
Walgreens Recalls Nice! Powdered Sugar Mini Donuts Due to Mold
Walgreens is recalling Nice! Powdered Sugar Mini Donuts because they may contain mold. Alleged illnesses have been reported in connection with this product.
Product
Nice! Powdered Sugar Mini Donuts 11.5 oz packaged in a white and pink box with with pink and black lettering.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1472-2015·2015-07-08
Snoqualmie Cookie Dough Custard Recalled for Listeria Risk
Snoqualmie Gourmet Ice Cream is recalling Cookie Dough Custard due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 3-gallon tubs.
Product
Cookie Dough Custard, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1180-2015·2015-07-08
Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling Fluorouracil IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
Product
Fluorouracil 4600mg / D5W 292 mL, Qty: 1 292 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1199-2015·2015-07-08
Lincare Recalls Cefepime HCl IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling Cefepime HCl IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
Product
Cefepime HCl, CEFEPIME 850 mg NS 50mL AccuFlo, Qty: 12 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereNHTSA·15V435000·2015-07-08
Ditch Witch T14MV Trailer Recall for Brake Wiring Defect
Charles Machine Works is recalling 2014-2015 Ditch Witch T14MV trailers due to a wiring defect that may prevent brakes from applying during a breakaway.
Product
DITCH WITCH — DITCH WITCH T14MV
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1892-2015·2015-07-08
Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1194-2015·2015-07-08
Lincare Recalls Pfizerpen-G IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling Pfizerpen-G IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
Product
Pfizerpen-G 4.2 MU / SW 240 mL AccuFlo, Packaged in 2 240 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-1954-2015·2015-07-08
ViewRay Treatment Planning Software Recalled for Location Calculation Failure
ViewRay is recalling Treatment Planning and Delivery System Software version 3.6 because it fails to determine new patient locations if imaging is not enabled.
Product
Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Category
Medical Device
Distribution
3 states
SevereFDA (Drugs)·D-1157-2015·2015-07-08
Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns
Lincare, Inc. is recalling TPN 3:1 bags compounded by United Medical IV Center because the sterility of the product is not assured.
Product
TPN 3:1, 1800 ml Bags, Qty: 2, Base Formula NaCl 0.9%, Dextrose 70%, Travasol 10%, Intralipid 20%, Water; Electrolytes K Phos, Mag Sulfate, KCL, Ca Gluconate; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only. Compounded by: United Medical IV Center…
Category
Drug
Distribution
1 state
SevereFDA (Food)·F-1497-2015·2015-07-08
Snoqualmie Blood Orange Sorbet Recalled for Listeria Risk
Snoqualmie Gourmet Ice Cream is recalling Blood Orange Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 3-gallon tubs.
Product
Blood Orange Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1181-2015·2015-07-08
Lincare Recalls Vancomycin Syringes Due to Sterility Assurance Concerns
Lincare, Inc. is recalling Vancomycin HCL 250mg syringes compounded by United Medical IV Center in Arkansas because the sterility of the product is not assured.
Product
VANCOMYCIN HCL 250mg / NS 6mL syringe, Packaged in 6 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-1857-2015·2015-07-08
Palindrome SI Chronic Catheter Sport Pack Recalled for Antimicrobial Deficiency
FDA Class II recall of Palindrome SI Chronic Catheter Sport Packs by Covidien LLC due to potential failure to meet antimicrobial specifications.
Product
Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm Item Code: 8888233508
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1870-2015·2015-07-08
Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Failure
Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.
Product
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1938-2015·2015-07-08
Atrium Medical Recalls EXPRESS Dry Seal Chest Drains Due to Missing O-Ring
Atrium Medical Corporation is recalling EXPRESS Dry Seal Chest Drains because they have a missing o-ring. The recall affects 390 cases distributed in the US, Canada, and Germany.
Product
EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1885-2015·2015-07-08
FDA Recalls Palindrome Precision Chronic Catheters for Antimicrobial Specification Failure
FDA is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123408P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1901-2015·2015-07-08
Palindrome Precision HSI Chronic Catheter Kit Recalled for Antimicrobial Defect
Covidien LLC is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications.
Product
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049CP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1955-2015·2015-07-08
JustRight 5mm Stapler Recalled for Incomplete Staple Formation
Justright Surgical is recalling JustRight 5mm Staplers because they may deliver incomplete staple formation and incomplete tissue closure.
Product
JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, placed in a tray and sealed with a Tyvek lid. Product Usage: The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for the resection, transection, and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1909-2015·2015-07-08
Palindrome Precision HSI Chronic Catheters Recalled for Antimicrobial Specification Failures
Covidien LLC is recalling Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.
Product
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1871-2015·2015-07-08
Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Failure
Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063CP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1853-2015·2015-07-08
Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1963-2015·2015-07-08
Hamilton Medical Infant Flow Sensor Recalled for Inaccurate Ventilation Measurements
Hamilton Medical is recalling Infant Flow Sensors because inaccurate flow measurements may cause ventilators to decrease ventilation delivery.
Product
Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1852-2015·2015-07-08
Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
FDA Class II recall of Palindrome SI Chronic Catheter Kits by Covidien LLC because the devices may not meet antimicrobial specifications.
Product
Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1878-2015·2015-07-08
Covidien Recalls Palindrome Precision SI Chronic Catheter Kits
FDA Class II recall of Palindrome Precision SI Chronic Catheter Kits due to potential failure to meet antimicrobial specifications.
Product
Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1847-2015·2015-07-08
Medtronic Recalls Navigated Cannulated Taps Due to Cleaning Injury Risk
Medtronic Navigation is correcting 15,798 Navigated Cannulated Taps distributed worldwide due to a potential for injury during the cleaning process.
Product
Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1982-2015·2015-07-08
GE Healthcare Recalls Innova IGS 540 Angiographic X-ray Systems
GE Healthcare is recalling six Innova IGS 540 angiographic X-ray systems due to a potential safety issue that may result in the loss of C-arm gantry motion capability.
Product
GE Healthcare Innova IGS 540. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1964-2015·2015-07-08
Hamilton Medical Infant Flow Sensor Recalled for Inaccurate Ventilation Measurements
Hamilton Medical is recalling Infant Flow Sensors because they may provide inaccurate flow measurements, causing ventilators to decrease ventilation in specific modes.
Product
Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1911-2015·2015-07-08
FDA Recalls Palindrome Precision HSI Chronic Catheters for Antimicrobial Defects
The FDA is recalling Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1980-2015·2015-07-08
GE Healthcare Recalls Innova IGS 520 Angiographic X-ray Systems
GE Healthcare is recalling 10 Innova IGS 520 angiographic X-ray systems due to a potential safety issue that may result in the loss of C-arm gantry motion capability.
Product
GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1983-2015·2015-07-08
GE Healthcare Recalls Innova IGS 620 Angiographic X-ray Systems
GE Healthcare is recalling three Innova IGS 620 angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.
Product
GE Healthcare Innova IGS 620. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1872-2015·2015-07-08
Palindrome Precision SI Chronic Catheter Kit Recall for Antimicrobial Failure
Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications.
Product
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1965-2015·2015-07-08
Hamilton Medical Infant Flow Sensor Recalled for Inaccurate Ventilation Measurements
Hamilton Medical is recalling Infant Flow Sensors because inaccurate flow measurements may cause ventilators to decrease ventilation delivery.
Product
Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1948-2015·2015-07-08
Zimmer Recalls Natural Knee II Revision Femoral Stems Due to Sterility Breach
Zimmer, Inc. is recalling 352 Natural Knee II Revision Femoral Stems because a breach in the sterile barrier could lead to periprosthetic infection.
Product
Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1854-2015·2015-07-08
Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units distributed worldwide with expiry dates of February 2018 and earlier.
Product
Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1932-2015·2015-07-08
Abbott ICT Serum Calibrator Recalled for Inaccurate Potassium Results
Abbott Laboratories is recalling ICT Serum Calibrator REF 146-03 because it may generate lower than expected Potassium results on the Abbott Architect cSystem.
Product
ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1864-2015·2015-07-08
Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1908-2015·2015-07-08
Covidien Recalls Chronic Catheters That May Not Meet Antimicrobial Specifications
Covidien LLC is recalling specific lots of Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1922-2015·2015-07-08
Roche Creatinine Plus Reagent Recalled for Potential Drug Interference
Roche Diagnostics is recalling Creatinine Plus reagents because acetaminophen and N-acetylcysteine may cause falsely decreased test results.
Product
Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1906-2015·2015-07-08
Palindrome HSI Chronic Catheter Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
Product
Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1875-2015·2015-07-08
Palindrome Precision SI Chronic Catheter Kit Recall for Antimicrobial Defects
Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cmItem Code: 8888145065CP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1874-2015·2015-07-08
FDA Recalls Palindrome Precision SI Chronic Catheter Kits for Antimicrobial Defects
The FDA is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
Product
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1977-2015·2015-07-08
GE Healthcare Recalls Innova 2121IQ Angiographic X-ray Systems
GE Healthcare is recalling Innova 2121IQ angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.
Product
GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1848-2015·2015-07-08
Pega Medical Recalls SCFE Drivers Due to Handle Detachment Risk
Pega Medical Inc. is recalling four units of SCFE Drivers because the handle may detach from the shaft during use.
Product
Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
Category
Medical Device
Distribution
2 states
HighFDA (Food)·F-2785-2015·2015-07-08
Sunridge Coconut Chews Recalled for Stainless Steel Wire Fragments
Falcon Trading Co. is recalling Sunridge Coconut Chews due to the presence of stainless steel wire fragments in the shredded coconut.
Product
Sunridge Candy-Coconut Chews, Vanilla. 10 lb. box. Item code: 023617; UPC: 086700936177 Falcon Trading Company Inc/Sun Ridge Farms, Royal Oaks, CA
Category
Food
Distribution
5 states
HighFDA (Devices)·Z-1918-2015·2015-07-08
New Star Lasers Recalls StoneLight 30 Laser Systems Due to Energy Discrepancy
New Star Lasers is recalling 52 StoneLight 30 Laser Systems because a software issue may cause the delivered energy to differ from the displayed value.
Product
StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy…
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1978-2015·2015-07-08
GE Healthcare Recalls Innova 3100IQ Angiographic X-ray Systems
GE Healthcare is recalling six Innova 3100IQ angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.
Product
GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1981-2015·2015-07-08
GE Healthcare Recalls Innova IGS 530 Angiographic X-ray Systems
GE Healthcare is recalling 17 Innova IGS 530 angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.
Product
GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1975-2015·2015-07-08
GE Healthcare Recalls Angiographic X-ray Systems Due to Motion Loss
GE Healthcare is recalling three Discovery and Innova IGS 740 angiographic X-ray systems because they may lose C-arm gantry motion capability.
Product
GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1886-2015·2015-07-08
Covidien Recalls Palindrome Precision SI Chronic Catheters for Antimicrobial Issues
Covidien LLC is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1893-2015·2015-07-08
Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
The FDA is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145049C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1966-2015·2015-07-08
GE Healthcare Radiographic Systems Recalled for Safety Mechanism Failure
GE Healthcare is recalling Precision 500D and Advantx Legacy systems because a safety mechanism may fail to engage, posing a risk of injury from falling equipment.
Product
GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1976-2015·2015-07-08
GE Healthcare Recalls Innova 2100IQ Angiographic X-ray Systems
GE Healthcare is recalling 13 Innova 2100IQ angiographic X-ray systems due to a potential safety issue that may cause the loss of C-arm gantry motion capability.
Product
GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1883-2015·2015-07-08
Palindrome SI Chronic Catheter Recall for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1962-2015·2015-07-08
Siemens Rapidlab 1265 Blood Gas Analyzer Recalled for Diagnostic Error Code Failure
Siemens Healthcare Diagnostics is recalling 2,713 Rapidlab 1265 blood gas analyzers because specific diagnostic error codes are not functional.
Product
The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1884-2015·2015-07-08
Recall of Palindrome Precision SI Chronic Catheters Due to Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Product
Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119368P
Category
Medical Device
Distribution
Distributed nationwide

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