Medical DeviceJun 5, 2019
K2M Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System recall — FDA Z-1492-2019
The products are mislabeled.
Class IIFDA: TerminatedK2M, Inc.
Monthly breakdown
2019 recalls by month
Select a month to review the recall records reported during that period.
December 2019321 records · 4 categoriesNovember 2019597 records · 4 categoriesOctober 2019525 records · 4 categoriesSeptember 2019268 records · 4 categoriesAugust 2019505 records · 4 categoriesJuly 2019680 records · 4 categoriesJune 2019445 records · 4 categoriesMay 2019396 records · 4 categoriesApril 2019242 records · 4 categoriesMarch 2019250 records · 4 categoriesFebruary 2019381 records · 4 categoriesJanuary 2019142 records · 4 categories
2019 recalls — page 131
Records are ordered by the best available source date.
Medical DeviceJun 5, 2019
Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32 Material:701055142 recall — FDA Z-1537-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
Maquet Getinge-BO-TOP 36504 ADULT ECC PACK Material: 701065765 recall — FDA Z-1573-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
Maquet Getinge-T 8029 PRESSURE PIGTAIL 6" Material: 701055995 recall — FDA Z-1545-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
Maquet Getinge-BEQ-T 27602 709000417 Adult Custom Pack Material: 709000417 recall — FDA Z-1616-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
Maquet Getinge: (1) Material: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF32 & HMOD (2) recall — FDA Z-1646-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8 Material: 709000428 recall — FDA Z-1619-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
PF Consumer Healthcare 1 ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, SKU: a) recall — FDA Z-1496-2019
There is the potential that a HeatWrap could include cells that have a higher cell temperature than specified in lot S97473. The use of heat cell wrap with increased temperatures poses a…
Class IIFDA: TerminatedPF Consumer Healthcare 1 LLC
Medical DeviceJun 5, 2019
Terumo Medical SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935 recall — FDA Z-1375-2019
There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the…
Class IFDA: TerminatedTerumo Medical Corporation
Medical DeviceJun 5, 2019
Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material:701050859R01 recall — FDA Z-1639-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
Maquet Getinge-BEQ-T 28906 1/4" with Bridge Ancillary P Material: 709000072 recall — FDA Z-1599-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 Material: 701051179 recall — FDA Z-1515-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
Maquet Getinge-BEQ-TOP 47800 STRINGFELLOW PED Material:701066583 recall — FDA Z-1580-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
Maquet Getinge-BEQ-TOP 31603 CHKD 3/8" ECC Material: 709000516 recall — FDA Z-1626-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
Maquet Getinge- (1) Material: 701063255R01 BEQ-TOP 25003 3/8 3/8 up to 7lpm (2) Material recall — FDA Z-1658-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
Maquet Getinge- (1) Material: 701055490R01 BEQ-TOP 15801 ¿ inch ECC Pack (2) Material recall — FDA Z-1653-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack Material: 709000006 recall — FDA Z-1596-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
Maquet Getinge-BEQ-T 3501 LVAD/ 3/8" Material: 701068008 recall — FDA Z-1590-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material: 701048539 recall — FDA Z-1500-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK Material: 701055372 recall — FDA Z-1538-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
Maquet Getinge-BEQ-TOP 41200 ECC 1/4 PUMP PAC Material: 701063149 recall — FDA Z-1553-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
Maquet Getinge-BEQ-TOP 25503 TMC ¿ with BB & QiD Pedi Material:709000473 recall — FDA Z-1624-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
Maquet Getinge-BEQ-TOP 21506 ECC PACK Material:701064505 recall — FDA Z-1555-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceJun 5, 2019
Maquet Getinge-BO-T 41302 PRIMING LINES BUMC Material:701066291 recall — FDA Z-1577-2019
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
About the 2019 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.