Z-1021-2020Class II
AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N
Medtronic, Inc. / initiated 2020-01-11 / Terminated / root cause: supplier
Cardinal Health began a recall of AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N on . FDA classified it as Class II and gives the reason as "The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination". As of , the recall status on record is Terminated, and MDM tags the root cause as supplier.
Recall record
- Recall number
- Z-1021-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Medtronic, Inc.
- Product
- AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N
- Product code
- FYA Gown, Surgical
- Reason for recall
- The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Root cause tag
- supplier
- FDA root cause
- 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.
- Product codes and lots
- Lot Numbers: XXXXXJ or XXXXXJX 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
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1002-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1003-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1004-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1005-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1006-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1007-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1008-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1009-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1010-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1011-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1012-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1013-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1014-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1015-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1016-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1017-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1018-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1019-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1020-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1021-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1022-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1023-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1024-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1025-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1026-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1027-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1028-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1029-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1030-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1031-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1032-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1033-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1034-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1035-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1036-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1037-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1038-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1039-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1040-2020 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.