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
- Lot codes and dates
1,804 of 1,804 products
Products covered by this recall # Product as published 1 Catalog Number and Lot Code: PB08GAGHS 521235 2 PB08GAGHS 529320 3 PB08GAGHS 554815 4 PB08GAGHS 557236 5 PB08GAGHS 560162 6 PB08GAGHS 562676 7 PB08GIGHR 552864 8 PB08GIGHR 559707 9 PB08GIGHR 561420 10 PB08HSGH5 517846 11 PB08HSGHK 504968 12 PB08HSGHK 544674 13 PB08HSGHK 554810 14 PB08HSGHK 558443 15 PB08HSGHK 562679 16 PB08IVGH3 519354 17 PB08IVGHO 503340 18 PB08IVGHO 509979 19 PB08IVGHO 551950 20 PB08IVGHO 554195 - Amount recalled
- 318,000 units
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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Cardinal Health 200, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.