Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm,

FDA device recall Z-2113-2020 · posted 2020-06-01 · Terminated

Recall details

Recalling firm

Stryker Sustainability Solutions

Reason for recall

A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual shelf life is one year. The earliest affected product will expire in May 2020. Use of mislabeled devices may lead to hazards sterility breach, component breakdown or delay in treatment.

Action taken

The firm will execute the recall in four phases: 1) Provide the Urgent Medical Device Recall Customer Notification Letter and Recall Business Reply Form to sales representatives via UPS on 3/27/2020 to notify affected customers; 2) Send the Urgent Medical Device Recall Customer Notification Letter and Recall Business Reply Form directly to affected customers; 3) Follow up phone calls and/or emails to nonrespondent customers as needed; 4) Additional follow up attempts to non-respondent customers as needed. The Urgent Medical Device Recall Customer Notification Letter and Recall Business Reply Form, dated March 2, 2020 instructs customers the following: The following Customer Actions are communicated in the Urgent Medical Device Recall Customer Notification Letter: Affected products may continue to be used prior to the one-year shelf life expiration. All products used prior to May 2020 are within the validated shelf life. 1. Please check your inventory for the affected devices. Affected devices may be identified through Serial Number (see Attachments 1 and 2). 2. Please complete the Urgent Medical Device Recall Business Reply Form (page 5) and indicate if any of the affected product remains in your inventory. Please return this completed form through one of the following methods: a. Email: SSSPFA@stryker.com b. To your Stryker Sustainability Solutions Sales Representative c. Fax: 480-763-5345 All faxes sent to 480-763-5345 will redirect to the SSSPFA@stryker.com email inbox. This email inbox will be monitored and customer responses will be documented to determine which customers have responded to the recall notification This form must be completed and returned to Stryker even if no affected product is found. 3. If any of the affected devices have been forwarded to additional facilities, please contact these facilities and communicate this recall to them. 4. Maintain awareness of this communication internally until all required ac

Root cause

Labeling False and Misleading

Status

Terminated

Product code

OWQ

Quantity affected

101 units

Distribution

US: AZ, CA, FL, GA, ID, IL, IN, KS, MA, MO, PA, TN, TX, VA, WA, WV OUS: None

Date initiated

2020-03-27

Date posted

2020-06-01

Date terminated

2022-10-14

Location

Tempe, AZ

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