SPS Sterilization, Inc: 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.

Agency Publication Date: September 13, 2018

Affected Products

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

Code Number AAO24TFA-R; Lot Number 59736014; Serial Numbers 16504192017-01, 16504192017-02, 16504192017-03, 16504192017-04, 16504192017-05, 16504192017-06, 16504192017-07, 16504192017-08, 16504192017-09, 16504192017-10

Lot Numbers:

Number

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

Code Number EZC24A-R; Lot Number 59634962; Serial Numbers 16401032017-01, 16401032017-02, 16401032017-03, 16401032017-04, 16401032017-05, 16401032017-06, 16401032017-07, 16401032017-08, 16401032017-09, 16401032017-10, 16401032017-11, 16401032017-12, 16401032017-13, 16401032017-14, 16401032017-15, 16401032017-16, 16401032017-17, 16401032017-18, 16401032017-19, 16401032017-20, 16401032017-21, 16401032017-22, 16401032017-23, 16401032017-24, 16401032017-25, 16401032017-26, 16401032017-27, 16401032017-28, 16401032017-29, 16401032017-30, 16401032017-31, 16401032017-32, 16401032017-33, 16401032017-34, 16401032017-35, 16401032017-36, 16401032017-37

Lot Numbers:

Number

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

Code Number TF038L-R; Lot Number 59634935; Serial Numbers 18302172017-01, 18302172017-02, 18302172017-03, 18302172017-04, 18302172017-05, 18302172017-06, 18302172017-07, 18302172017-08, 18302172017-09, 18302172017-10

Lot Numbers:

Number

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

Code Number TF034L-R; Lot Number 59739865; Serial Numbers 18304192017-12, 18304192017-13, 18304192017-14, 18304192017-15, 18304192017-16

Lot Numbers:

Number

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

Code Number TF293702-R; Lot Number 59655659; Serial Numbers 18304192017-02, 18304192017-03, 18304192017-04, 18304192017-05, 18304192017-06

Lot Numbers:

Number

Product: Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.

Code Number VFEM018-R; Lot Number 59740463; Serial Number 16704192017-01

Lot Numbers:

Number

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

Code Number VFEM020-R; Lot Number 59691447; Serial Number 16704032017-01

Lot Numbers:

Number

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

Code Number OPTI22-R; Lot Number 59637295; Serial Number 16502032017-01

Lot Numbers:

Number

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

Code Number 40213-R; Lot Number 18030192; Serial Number 21408032017-10, 21408032017-11

Lot Numbers:

Number

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

Code Number 40451-R; Lot Number 18098774; Serial Number 21408032017-12, 21408032017-13

Lot Numbers:

Number

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

Code Number 40512-R; Lot Number 17984215; Serial Number 21408032017-14, 21408032017-15

Lot Numbers:

Number

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

Code Number 6559-R; Lot Number 17252887 (Serial Number 16211282016-02); Lot Number 17465176 (Serial Numbers 97403172017-16, 97403172017-40)

Lot Numbers:

Number

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

Code Number 71130-R; Lot Number 17401915; Serial Number 21408032017-01, 21408032017-02

Lot Numbers:

Number

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

Code Number 71139-R; Lot Numbers 17752073, 17752073, 17422520; Serial Numbers 21408032017-03, 21408032017-04, 21408032017-05

Lot Numbers:

Number

Numbers

Product: Vascular Solutions Venture Rx Catheter, 6F, resterilized.

Code Number 5820-R; Lot Number 570183 (Serial Number 99804132016-07); Lot Number 583022 (Serial Number 17304202017-07, 17304202017-08)

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80317

Status: Resolved

Manufacturer: SPS Sterilization, Inc

Manufactured In: United States

Units Affected: 15 products (10 units total; 6 units total; 10 units total; 5 units total; 5 units total; 1 unit total; 1 unit total; 1 unit total; 2 units total; 2 units total; 2 units total; 2 units total; 2 units total; 3 units total; 3 units total)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

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

Lot Numbers:

Number

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

Lot Numbers:

Number

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

Lot Numbers:

Number

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

Code Number TF034L-R; Lot Number 59739865; Serial Numbers 18304192017-12, 18304192017-13, 18304192017-14, 18304192017-15, 18304192017-16

Lot Numbers:

Number

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

Code Number TF293702-R; Lot Number 59655659; Serial Numbers 18304192017-02, 18304192017-03, 18304192017-04, 18304192017-05, 18304192017-06

Lot Numbers:

Number

Product: Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.

Code Number VFEM018-R; Lot Number 59740463; Serial Number 16704192017-01

Lot Numbers:

Number

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

Code Number VFEM020-R; Lot Number 59691447; Serial Number 16704032017-01

Lot Numbers:

Number

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

Code Number OPTI22-R; Lot Number 59637295; Serial Number 16502032017-01

Lot Numbers:

Number

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

Code Number 40213-R; Lot Number 18030192; Serial Number 21408032017-10, 21408032017-11

Lot Numbers:

Number

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

Code Number 40451-R; Lot Number 18098774; Serial Number 21408032017-12, 21408032017-13

Lot Numbers:

Number

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

Code Number 40512-R; Lot Number 17984215; Serial Number 21408032017-14, 21408032017-15

Lot Numbers:

Number

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

Code Number 6559-R; Lot Number 17252887 (Serial Number 16211282016-02); Lot Number 17465176 (Serial Numbers 97403172017-16, 97403172017-40)

Lot Numbers:

Number

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

Code Number 71130-R; Lot Number 17401915; Serial Number 21408032017-01, 21408032017-02

Lot Numbers:

Number

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

Code Number 71139-R; Lot Numbers 17752073, 17752073, 17422520; Serial Numbers 21408032017-03, 21408032017-04, 21408032017-05

Lot Numbers:

Number

Numbers

Product: Vascular Solutions Venture Rx Catheter, 6F, resterilized.

Code Number 5820-R; Lot Number 570183 (Serial Number 99804132016-07); Lot Number 583022 (Serial Number 17304202017-07, 17304202017-08)

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80317

Status: Resolved

Manufacturer: SPS Sterilization, Inc

Manufactured In: United States