Reported Feb 26, 2020 · Terminated
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September…
Cardinal Health 200, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health 200, LLC · 3651 Birchwood Dr · Waukegan, IL · 60085-8337
Is this the product you have?
- Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
- Lot codes and dates
1,715 of 1,715 products
Products covered by this recall # Product as published 1 Catalog Number and Lot Code: CHIP99CP6C 241107 2 CHIP99CP6C 255309 3 CHIP99CP6C 299932 4 CHIP99CP8A 181346 5 CHIP99CP8A 282695 6 CHIP99CP8A 282696 7 CHIP99CP8A 282697 8 CHIP99HA1B 165018 9 CHIP99HA1B 248383 10 CHIP99HA1B 305740 11 CHIP99HA1B 330666 12 CHIP99HA1B 330666 13 CHIP99HA1B 363766 14 CHIP99LC1F 118473 15 CHIP99LC1F 279185 16 CHIP99LC1F 298252 17 CHIP99LC1F 309240 18 CHIP99LC1F 340201 19 CHIP99LC1F 340315 20 CHIP99LC1F 367435 - Amount recalled
- 2,161,526 units (113, 711 additional units as of 2/25/20)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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