ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998

FDA device recall Z-1024-2020 · posted 2020-01-24 · Terminated

Recall details

Recalling firm

Cardinal Health

Reason for recall

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

Action taken

A letter dated 1/11/20 informed customers that: Cardinal Health has become aware of a quality issue related to the manufacture of certain AAMI Level 3 surgical gowns. We have initiated an investigation, placed a hold on product inventory, and are working with the U.S. Food and Drug Administration (FDA) to address this issue. This inventory hold affects certain lots of bulk non-sterile and single-sterile Cardinal Health" surgical gowns and Presource procedure packs that include these surgical gowns. Your local sales representative will provide specific details. Cardinal Health intends to initiate a product recall and will provide you with instructions soon. In the meantime, discontinue use and segregate all affected surgical gowns and Presource procedural packs that include these affected surgical gowns from your current inventory. These actions will cause a supply disruption, and we are prepared to suggest alternate surgical gowns and pack components you may need during this time. Please note that our process will initially place all impacted Presource procedure packs on a short-term hold as we work through the process. This should not impact your broader base of inventory. For Presource packs currently in production, we will include gowns with similar fit, form and function, where possible, with no change in cost, or run without the product or suggest an alternate, comparable single-sterile gown. Your sales representative will work with you to identify alternative pack components needed to perform your procedures. We recognize the criticality of our gowns and procedure packs to performing surgeries, and we apologize for the challenges this supply disruption will cause. Cardinal Health puts the safety of patients and health care workers first. We appreciate your understanding and patience during this time. An Urgent Medical Device Recall notification letter dated 1/21/20 was sent to customers. Actions Required: 1. CHECK all storage and usage

Root cause

Vendor change control

Status

Terminated

Product code

FYA

Quantity affected

7,659,634 total units

Distribution

Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines

Date initiated

2020-01-11

Date posted

2020-01-24

Date terminated

2023-01-19

Location

Waukegan, IL

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