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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm January 11, 2020
Date Posted January 24, 2020
Recall Status1 Terminated 3 on January 19, 2023
Recall Number Z-1034-2020
Recall Event ID 84733
510(K)Number K020593  
Product Classification Gown - Product Code FYA
Product AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511
Code Information Lot Numbers: XXXXJXXX  Single-Sterile Lot Format: YYMRJXXX  Where: YY Last two digits of the year ( 18 or '19)  M Month in alpha code   " If made in 2018 o J for September   o K for October   o L for November OR   o M for December     " If made in 2019, any value is affected  R Product revision or suffix  P Facility code is letter J  XXX Sequential Number - Monthly reset   OR  Bulk Non-Sterile Lot Format: XXXYRPQ  Where: XXX Elapsed days of year  " " If made in 2018, 244 or greater is affected OR  " " If made in 2019, any value is affected; see below for year made identifier  Y Last character of year gown was made (2018 or 2019)  R Product Revision  P Facility code is letter J  Q Plant shift identifier; this identifier was added during the affected time period and therefore older product may not contain this digit in the lot number
Recalling Firm/
Manufacturer		 Cardinal Health
1350 Bridge Dr
Waukegan IL 60085-6306
For Additional Information Contact Erica Lewis
614-757-0087
Manufacturer Reason
for Recall		 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
FDA Determined
Cause 2		 Vendor change control
Action 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
Quantity in Commerce 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, and Saudi Arabia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FYA and Original Applicant = ALLEGIANCE HEALTHCARE CORP.
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