Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 29 of 63

Nakanishi Inc.

Class II Terminated

Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, 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-0223-2019 October 31, 2018 Kanuma, N/A

Nakanishi Inc.

Class II Terminated

Surgical Handpiece, Model: SGA-E Order Code: H083, 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-0221-2019 October 31, 2018 Kanuma, N/A

Nakanishi Inc.

Class II Terminated

Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, 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-0225-2019 October 31, 2018 Kanuma, N/A

SPS Sterilization, Inc

Class II Terminated

Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.

Reason: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life...

Z-3032-2018 September 19, 2018 Nixa, MO

SPS Sterilization, Inc

Class II Terminated

Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM, resterilized.

Reason: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life...

Z-3040-2018 September 19, 2018 Nixa, MO

SPS Sterilization, Inc

Class II Terminated

Vascular Solutions Venture Rx Catheter, 6F, resterilized.

Reason: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life...

Z-3041-2018 September 19, 2018 Nixa, MO

SPS Sterilization, Inc

Class II Terminated

Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.

Reason: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life...

Z-3029-2018 September 19, 2018 Nixa, MO

SPS Sterilization, Inc

Class II Terminated

Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, resterilized.

Reason: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life...

Z-3037-2018 September 19, 2018 Nixa, MO

SPS Sterilization, Inc

Class II Terminated

Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized.

Reason: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life...

Z-3033-2018 September 19, 2018 Nixa, MO

SPS Sterilization, Inc

Class II Terminated

Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.

Reason: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life...

Z-3031-2018 September 19, 2018 Nixa, MO

SPS Sterilization, Inc

Class II Terminated

Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.

Reason: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life...

Z-3030-2018 September 19, 2018 Nixa, MO

SPS Sterilization, Inc

Class II Terminated

Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CM L, resterilized.

Reason: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life...

Z-3036-2018 September 19, 2018 Nixa, MO

SPS Sterilization, Inc

Class II Terminated

Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.

Reason: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life...

Z-3028-2018 September 19, 2018 Nixa, MO

SPS Sterilization, Inc

Class II Terminated

Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.

Reason: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life...

Z-3027-2018 September 19, 2018 Nixa, MO

SPS Sterilization, Inc

Class II Terminated

Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.

Reason: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life...

Z-3034-2018 September 19, 2018 Nixa, MO

SPS Sterilization, Inc

Class II Terminated

Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.

Reason: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life...

Z-3038-2018 September 19, 2018 Nixa, MO

SPS Sterilization, Inc

Class II Terminated

Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized.

Reason: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life...

Z-3039-2018 September 19, 2018 Nixa, MO

SPS Sterilization, Inc

Class II Terminated

Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.

Reason: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life...

Z-3035-2018 September 19, 2018 Nixa, MO

Medline Industries, Inc.

Class II Terminated

Cardiac Insulation Pad, OPEN HEART CDS

Reason: Complete delivery System (CDS) # CDS984746C was assembled using a non-sterile cardiac insulation pad, Medline component number 32369. The non-sterile component (32369) was placed w...

Z-2979-2018 September 12, 2018 Waukegan, IL

Medline Industries, Inc.

Class II Terminated

Laparoscopy CDS

Reason: One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to b...

Z-2978-2018 September 12, 2018 Waukegan, IL

Medline Industries, Inc.

Class II Terminated

LASER CDS

Reason: Multiple surgical packs were assembled with a non-sterile CHG applicators labeled as "ChloraPrep" (kit component numbers: 29183, 52115, 82279, and 82281). The non-sterile component...

Z-2980-2018 September 12, 2018 Waukegan, IL

Steris Corporation

Class II Terminated

AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC Sterilant, are inte...

Reason: There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterila...

Z-2959-2018 September 12, 2018 Mentor, OH

Encore Medical, Lp

Class II Terminated

Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and transport instrumentation to be used in orthopedic surger...

Reason: A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.

Z-2600-2018 August 8, 2018 Austin, TX

Fort Defiance Industries, LLC

Class II Terminated

FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for ...

Reason: During long-term storage (i.e. military depot), the interaction of stagnant water and dissimilar metals in the plumbing of the P2131 device produces deposits in the water system th...

Z-2411-2018 July 18, 2018 Loudon, TN

Anika Therapeutics, Inc.

Class II Terminated

Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care devic...

Reason: Hyalomatrix products are susceptible to degradation as a result of the decomposition of PVC in the packaging material during sterilization, which resulted in degradation of the fil...

Z-2423-2018 July 18, 2018 Bedford, MA