Agency classClass IIOur severity:Moderate FDA (Devices)·Z-3028-2018·Announced 2018-09-19

SPS Sterilization Recalls Edwards Lifesciences Aortic Cannula Due to Labeling Error

SPS Sterilization is recalling 6 units of Edwards Lifesciences EZ Glide Aortic Cannulas because the expiration date on the label exceeds the validated shelf life.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding shelf life without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

SPS Sterilization, Inc. is recalling 6 units of Edwards Lifesciences EZ Glide Aortic Cannulas, 24F x 37.6CM, that were resterilized. The recall was initiated because the expiration date printed on the device labeling exceeds the actual validated shelf life of the product. This occurred because the sterilization process used did not have adequate support for the extended shelf life indicated on the label.

The affected devices were distributed in the United States to Arizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia, and West Virginia. The specific Code Number is EZC24A-R, and the Lot Number is 59634962. The recall includes 37 specific serial numbers ranging from 16401032017-01 to 16401032017-37.

Healthcare facilities and consumers should stop using these specific devices and contact SPS Sterilization, Inc. for further instructions or a return. This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
Manufacturer: SPS Sterilization, Inc
Category: Medical Device — Surgical Instrument
Hazard: mis-labeling
Affected units: 6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed in 8 states:

Part of a larger recall action

This product is one of 15 recalled by SPS Sterilization, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

Same manufacturer · SPS Sterilization, Inc

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Same hazard · mis labeling