1,565 results found for sterilization
Page 28 of 63
Maquet Cardiovascular, LLC
Class IITerminated
Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material: 701047962
Reason: 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 i...
Reason: 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 i...
Reason: 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 i...
Z-1630-2019June 5, 2019Wayne, NJ
Maquet Cardiovascular, LLC
Class IITerminated
Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory Material: 701055604R01
Reason: 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 i...
Reason: 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 i...
Z-1672-2019June 5, 2019Wayne, NJ
Maquet Cardiovascular, LLC
Class IITerminated
Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01
Reason: 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 i...
Z-1680-2019June 5, 2019Wayne, NJ
Maquet Cardiovascular, LLC
Class IITerminated
Maquet Getinge-BEQ-TOP 22600 ECC QUADROX iD 3/8 Material:701049440R02
Reason: 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 i...
Z-1633-2019June 5, 2019Wayne, NJ
Maquet Cardiovascular, LLC
Class IITerminated
Maquet Getinge-BEQ-T 5914 TCH ¿ Inch Change Kit Material: 709000334
Reason: 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 i...
Reason: 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 i...
Z-1583-2019June 5, 2019Wayne, NJ
COVIDIEN LLC
Class IITerminated
Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO (2)BOX KIT00680 KIT COLECISTECTOMIA- (3)BOX KIT00681 KIT APENDICECTOMIA (4)...
Reason: Sterilization method used was not consistent with the labeling and the approved sterilization method
Z-1213-2019May 1, 2019Mansfield, MA
COVIDIEN LLC
Class IITerminated
Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and ...
Reason: Sterilization method used was not consistent with the labeling and the approved sterilization method
Z-1212-2019May 1, 2019Mansfield, MA
COVIDIEN LLC
Class IITerminated
Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length an...
Reason: Sterilization method used was not consistent with the labeling and the approved sterilization method
Z-1211-2019May 1, 2019Mansfield, MA
Zimmer Biomet, Inc.
Class IITerminated
Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 41...
Reason: Lack of an adequate sterilization validation
Z-1081-2019April 10, 2019Warsaw, IN
COVIDIEN LLC
Class IITerminated
Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
Reason: The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.
Z-1041-2019April 3, 2019Mansfield, MA
American Contract Systems, Inc.
Class IITerminated
Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP LH - 2035102, Tray Number: LSRBASICPACD; b. Tray Name: P...
Reason: Potential that product has not reached complete sterilization,
Z-0964-2019March 6, 2019Bloomington, MN
XTANT MEDICAL INC
Class IITerminated
Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC 26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC 26mm x 10mm x 8m...
Reason: This recall has been initiated due to a change in packaging and sterilization method to address potential risks of compromised sterilization presented by the existing configuration...
Z-0790-2019February 6, 2019Belgrade, MT
Zimmer Biomet, Inc.
Class IITerminated
Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilizat...
Reason: There is a potential for silicone shedding during cleaning and sterilization.
Z-0734-2019January 23, 2019Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and steriliz...
Reason: There is a potential for silicone shedding during cleaning and sterilization.
Z-0735-2019January 23, 2019Warsaw, IN
Safe N Simple, LLC
Class IITerminated
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
Reason: The sterilization process used was unqualified.
Z-0401-2019November 14, 2018Clarkston, MI
Safe N Simple, LLC
Class IITerminated
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315
Reason: The sterilization process used was unqualified.
Z-0400-2019November 14, 2018Clarkston, MI
Nakanishi Inc.
Class IITerminated
Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant ...
Reason: Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previ...
Z-0226-2019October 31, 2018Kanuma, N/A
Nakanishi Inc.
Class IITerminated
Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping t...
Reason: Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The prev...
Z-0220-2019October 31, 2018Kanuma, N/A
Nakanishi Inc.
Class IITerminated
Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant u...
Reason: Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previ...
Z-0224-2019October 31, 2018Kanuma, N/A
Nakanishi Inc.
Class IITerminated
Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping th...
Reason: Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The prev...
Z-0219-2019October 31, 2018Kanuma, N/A
Nakanishi Inc.
Class IITerminated
Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping...
Reason: Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previ...