The Recall Desk

Archive

June 2019 recalls

686 recalls were announced in June 2019.

What the numbers show

Critical
12
Severe
212
High
329
Moderate
120
Low
13

Of the 686 recalls this month scored against our rubric, 2% are Critical, 31% are Severe.

Which agencies issued them

501–600 of 686

  • HighFDA (Food)·F-1418-2019·2019-06-05

    Fiddyment Farms Pistachios Recalled for Undeclared Soy Protein

    Fiddyment Farms is recalling various Fiddy Fire pistachio products because they contain undeclared hydrolyzed soy protein.

    Product
    Fiddyment Farms Fiddy Fire In-Shell Pistachios 2.5 oz., 8 oz., 1 lb., 2 lb., 3 lb., 5 lb., Fiddyment Farms Fiddy Fire Pistachio In Shell 25 lb.; Fiddyment Farms Fiddy Fire Gift Tin 6 oz.; Fiddyment Farms Gourmet Sampler 2.5 oz.; Fiddyment Farms Deluxe Pistachio Lovers Gift Box…
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1419-2019·2019-06-05

    Heritage Candy Recalls Dark Chocolate Nonpareils Due to Almond Contamination

    Heritage Candy Company is recalling 197 units of First Street Dark Chocolate Nonpareils because some bags contain dark chocolate almonds, posing a tree nut allergy risk.

    Product
    First Street Dark Chocolate Nonpareils; 12 oz. stand up re-sealable plastic bags. Ingredients: Sweet Chocolate (sugar, chocolate liquor, cocoa butter, butter oil, soy lecithin, vanilla extract) seeds (sugar, cornstarch). Contains: milk, soy. Manufactured in a facility…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1596-2019·2019-06-05

    Maquet Pediatric Cardiac Surgery Packs Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Pediatric Cardiac Surgery Packs because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack Material: 709000006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1623-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 8075 S-Quadrox iD Plus Pack wRF3 Material: 709000460
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1585-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 5208 ECC Set Cardiac Recall for Sterility Assurance

    Maquet Cardiovascular is recalling specific batches of cardiac extracorporeal circulation sets because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1662-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, compromising sterility.

    Product
    Maquet Getinge- BO-T 41301 BUMC ECC PACK Material: -701065209R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1558-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because the stopcock design may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 30601 CMC ACCESSORY KIT Material: 701064701
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1599-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 28906 1/4" with Bridge Ancillary P Material: 709000072
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2019·2019-06-05

    Maquet Getinge Small Adult Cardiac Surgery Tubing Sets Recalled for Sterility Concerns

    Maquet Cardiovascular is recalling specific Small Adult Cardiac Surgery Tubing Sets because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery Material:709000004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1549-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BEQ-T 39700 ECC PACK Material:701062473
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1566-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because the stopcock design may prevent sterilization gas from reaching all fluid paths.

    Product
    Maquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID Material: 701064992
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1559-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BEQ-TOP 24105 ECC PACK Material:701064757
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1636-2019·2019-06-05

    Maquet Getinge Adult ECC Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling Adult ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 24101 Adult ECC Pack Material:701050177R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1605-2019·2019-06-05

    Maquet Pediatric Cardiac Surgery Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific pediatric cardiac surgery tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge Material: 709000133
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1578-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 9405 LARGE PATIENT TBG P Material:701066366
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1531-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 33704 ECC 1/4" PACK Material: 701054150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1509-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent proper sterilization gas flow, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 22701 Material: 701050790
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1613-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation due to a sterilization defect that may compromise sterility.

    Product
    Maquet Getinge-BEQ-T 25501 3/8" Better Bladder Pack Material: 709000370
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2019·2019-06-05

    Maquet Getinge ROTAFLOW Support Pack Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling ROTAFLOW Support Packs because a design feature may prevent sterilization gas from reaching all parts, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 49002 ROTAFLOW SUPPORT PACK Material: 701067280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1684-2019·2019-06-05

    Teleflex Medical Recalls RUSCH LASERTUBE Due to Laser Guard Foil Separation

    Teleflex Medical is recalling 4,312 units of RUSCH LASERTUBE (Rubber) because the laser guard foil partially separated or detached at the edges.

    Product
    RUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm 6,0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1664-2019·2019-06-05

    Maquet Getinge Adult ECC Pack Tubing Sets Recalled for Sterility Concerns

    Maquet Cardiovascular is recalling specific adult extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BEQ-TOP 46700 ADULT ECC PACK Material:701065833R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1583-2019·2019-06-05

    Maquet Getinge Cardioplegia Packs Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Cardioplegia Packs because a design feature may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BEQ-T 4963 CARDIOPLEGIA PACK Material: 701067203
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1539-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all fluid paths.

    Product
    Maquet Getinge-BEQ-TOP 37200 CIRCULATORY CIRC Material: 701055388
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2019·2019-06-05

    Maquet Getinge Sash and Accessory Pack Recall for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Sash & Accessory Packs because a design flaw may prevent proper sterilization of stopcock ports.

    Product
    Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material:-709000266R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1551-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 40700 HUNTINGTON Material:701062899
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1609-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because the design may prevent sterilization gas from reaching all fluid paths.

    Product
    Maquet Getinge-BEQ-T 5915 TCH 3/8 Inch Change Kit Material: 709000280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1550-2019·2019-06-05

    Maquet Getinge Neonatal Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific neonatal tubing sets because a design feature may prevent sterilization gas from reaching all parts, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 2202 NEONATAL SPECIALT Material:701062613
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1567-2019·2019-06-05

    Maquet Getinge Pediatric ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific pediatric extracorporeal circulation tubing sets because the stopcock design may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 37302 Quadrox iD Pediatric Pack Material: 701065190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2019·2019-06-05

    Maquet Getinge-T AV Manifold Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific AV Manifold units for extracorporeal circulation because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-T 41303 AV MANIFOLD FOR ECC PA Material:701066551
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1598-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of ECC tubing sets because a design feature may prevent sterilization gas from reaching all fluid paths.

    Product
    Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder Material: 709000058
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1581-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy Material:701066664
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1529-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization of stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 33700 ECC 3/8" PACK Material: 701053845
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1631-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC tubing sets because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 17207 3/8" ECC Pack Material:701049346R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1534-2019·2019-06-05

    Maquet Getinge AV Loop Tubing Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific AV Loop tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP Material:701054776
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1606-2019·2019-06-05

    Maquet Getinge-BEQ-T 8506 Transport Pack Recalled for Sterility Assurance Issues

    Maquet Cardiovascular is recalling Custom Tubing Sets for Extracorporeal Circulation because the stopcock design may prevent sterilization gas from reaching the fluid path, compromising sterility.

    Product
    Maquet Getinge-BEQ-T 8506 Transport Pack Material: 709000146
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 51501 Ochsner ECC Pack Material:709000113
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1617-2019·2019-06-05

    Maquet Getinge Rotaflow Pack Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling Rotaflow Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 57000 Rotaflow Pack Material: 709000424
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1630-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 5103 CPS Tubing Pack Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific tubing packs for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 5103 CPS Tubing Pack Material:701048690R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1668-2019·2019-06-05

    Maquet Getinge Open Heart Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Open Heart Packs because a design feature may prevent sterilization gas from reaching all parts, potentially compromising sterility.

    Product
    Maquet Getinge BEQ-TOP 40010 OPEN HEART PACK Material: -701067364R02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1532-2019·2019-06-05

    Maquet Getinge Adult ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of adult extracorporeal circulation tubing sets because a design feature may prevent proper sterilization gas flow.

    Product
    Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material:701054295
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1520-2019·2019-06-05

    Maquet Getinge-BO-T 6600 Tubing Pack Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific tubing packs used for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, potentially compromising sterility.

    Product
    Maquet Getinge-BO-T 6600 TUBING PACK Material:701052324
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 41200 ECC 1/4 Pump Pac Tubing Sets Recalled

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 41200 ECC 1/4 PUMP PAC Material: 701063149
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1562-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 44200 MAYO PULMONARY P Material: 701064831
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1629-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material:701047962R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1545-2019·2019-06-05

    Maquet Getinge-T 8029 Pressure Pigtail Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Pressure Pigtail devices because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-T 8029 PRESSURE PIGTAIL 6" Material: 701055995
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1542-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID Material: 701055862
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1648-2019·2019-06-05

    Maquet Getinge Quadrox iD Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Quadrox iD Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BEQ-TOP 27700 Quadrox iD Pack Material: 701054389R02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1608-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material: 709000266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1587-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE Material: 701067577
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1656-2019·2019-06-05

    Maquet Getinge Infant ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific infant extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BEQ-TOP 28901 MCV INFANT ECC Material:701056771R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1667-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent proper sterilization gas flow, compromising sterility.

    Product
    Maquet Getinge- (1) Material: 701067350R01 BEQ-TOP 5208 ECC Small-Cardiac (2) material: 701067350R02 BEQ-TOP 5208 ECC Small-Cardiac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1685-2019·2019-06-05

    Teleflex Medical Recalls RUSCH LASERTUBE Devices Due to Foil Separation

    Teleflex Medical is recalling RUSCH LASERTUBE devices because the laser guard foil may partially separate or detach at the edges.

    Product
    RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1616-2019·2019-06-05

    Maquet Getinge Adult Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling Adult Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BEQ-T 27602 709000417 Adult Custom Pack Material: 709000417
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1555-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent proper sterilization gas flow.

    Product
    Maquet Getinge-BEQ-TOP 21506 ECC PACK Material:701064505
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 8208#3/8 inch ECC Pack Material: 701068798
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1514-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 15705 Material: 701051122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1517-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 5502 ECC Pack Recall for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of ECC packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 5502 ECC Pack Material: 701051791
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1672-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BEQ-TOP 35503 SGD Pack Material:701068797R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1513-2019·2019-06-05

    Maquet Getinge-BO-TOP 26300 Custom Tubing Sets Recalled for Sterility Assurance Issues

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design configuration may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BO-TOP 26300 CUSTOM PACK Material: 701050975
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1493-2019·2019-06-05

    Abbott TactiSys Quartz Equipment Recalled for Log Storage Defect

    Abbott is recalling 317 TactiSys Quartz Equipment units because a software defect prevents new log data from being stored, which may cause intermittent contact force data display.

    Product
    TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1523-2019·2019-06-05

    Maquet Pediatric ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific pediatric extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 31000 PEDIATRIC ECC Material:701052843
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1576-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 16405 LIVER TX INFUSION Material:701066097
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1677-2019·2019-06-05

    Maquet Getinge Rotaflow Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Rotaflow Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BEQ-T 53500 Evanston Rotaflow Pack Material:709000215R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1625-2019·2019-06-05

    Maquet Getinge Rotaflow Support Pack Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Rotaflow Support Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 48003 Rotaflow ONLY Support Pack Material:709000490
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1530-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all parts of the fluid path.

    Product
    Maquet Getinge-BEQ-TOP 25001 MONTEFIORE Material: 701053906
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1641-2019·2019-06-05

    Maquet Neonate ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific neonate extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 28601 NEONATE ECC QPiD Material: 701051935R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1502-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization.

    Product
    Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK Material: 701049346
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1621-2019·2019-06-05

    Maquet Getinge Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BEQ-T 25502 1/4 Better Bladder Material: 709000434
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1548-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 26402 ECC Pack Recall Due to Sterility Concerns

    Maquet Cardiovascular is recalling specific batches of ECC Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 26402 ECC PACK Material: 701062310
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1619-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8 Material: 709000428
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1649-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow.

    Product
    Maquet Getinge- BEQ-TOP 32100 Adult Custom Pack Material:701054438R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1691-2019·2019-06-05

    NeuroLogica Recalls Samsung GM85 Mobile Digital X-ray Imaging Systems

    NeuroLogica is recalling 288 Samsung GM85 Mobile Digital X-ray Imaging Systems due to a potential safety latch issue that could cause the arm to fall.

    Product
    Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1679-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization.

    Product
    Maquet Getinge- BEQ-T 9411 Lurie Children's 1/4 ADAPT Material:709000485R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1665-2019·2019-06-05

    Maquet Getinge Children's ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Children's Large ECC Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 49101 Childrens Large ECC Pack Material: 701067069R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1533-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 32100 ADULT CUSTOM PAC Material:701054438
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2019·2019-06-05

    Maquet Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK Material:701063071
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1645-2019·2019-06-05

    Maquet Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 250011/4 1/4 Less than 20 kg up Material: 701053906R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of custom tubing sets for extracorporeal circulation because the design may prevent proper sterilization gas flow.

    Product
    Maquet Getinge-BEQ-T 51502 Ochsner ECC Ancillary Pack Material:709000115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because the stopcock design may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BO-T 2303 3/8" x 3/8" Adult Pack Material: 709000004R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1569-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC tubing sets because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 27609 ECC PACK 1/4" Material: 701065504
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1503-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design configuration may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T-22800 Material: 701049506
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1570-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 31203 CUSTOM PACK NEO Material: 701065510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1600-2019·2019-06-05

    Maquet Pediatric ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling pediatric extracorporeal circulation tubing sets because a design flaw may prevent proper sterilization of stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 50903 Custom ECC Pack-Pedriatric Material: 709000078
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1498-2019·2019-06-05

    Maquet Getinge Tubing Packs Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific tubing packs for extracorporeal circulation because the design may prevent proper sterilization gas flow, compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1627-2019·2019-06-05

    Maquet Getinge-BEQ-TOP Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because the design may prevent proper sterilization gas flow, compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 31604 CHKD 1/4" ECC Material: 709000518
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1546-2019·2019-06-05

    Maquet Pediatric CPB Packs Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling Pediatric CPB Packs because a design feature may prevent sterilization gas from reaching all fluid paths, compromising sterility.

    Product
    Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK Material: 701056041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1618-2019·2019-06-05

    Maquet Getinge-T 5220 UAB Hospital Accessory Recall for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because the design may prevent proper sterilization gas flow, potentially compromising sterility.

    Product
    Maquet Getinge-T 5220 UAB Hospital Accessory Material: 709000426
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1604-2019·2019-06-05

    Maquet Getinge Cardioplegia Packs Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of Getinge-BO-T 52360 Cardioplegia Packs because a design feature may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BO-T 52360 Cardioplegia Pack Material: 709000127
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2019·2019-06-05

    Maquet Getinge-BEQ-T 3501 LVAD Tubing Sets Recalled for Sterility Assurance Issues

    Maquet Cardiovascular is recalling specific LVAD tubing sets because a design feature may prevent sterilization gas from reaching all parts, compromising sterility.

    Product
    Maquet Getinge-BEQ-T 3501 LVAD/ 3/8" Material: 701068008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1540-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent sterilization gas from reaching all fluid paths.

    Product
    Maquet Getinge-BEQ-TOP 37500 ECC QUADROX ID Material: 701055601
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1522-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because the design may prevent proper sterilization gas flow, compromising sterility.

    Product
    Maquet Getinge-BO-TOP 30300 Material:701052623
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1646-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge: (1) Material: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF32 & HMOD (2) Material: 701053941R02- BEQ-TOP 9005 3/8 Custom Pk w RF32 & HMOD Material:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1658-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge- (1) Material: 701063255R01 BEQ-TOP 25003 3/8 3/8 up to 7lpm (2) Material: 701063255R02 BEQ-TOP 25003 3/8 3/8 up to 7 lpm
    Category
    Medical Device
    Distribution
    Distributed nationwide

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